Instrumentation Laboratory Co.
Bedford, MA, US
INSTRUMENTATION LABORATORY CO. appears in FDA device records in Bedford, MA. FDA records list 327 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 104 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 327FDA records hold 327 510(k) clearances for Instrumentation Laboratory Co. between 1976 and 2023. The busiest year on record is 1977, with 31. The most recent is 2023, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 10 |
| 1977 | 31 |
| 1978 | 7 |
| 1979 | 1 |
| 1980 | 8 |
| 1981 | 4 |
| 1982 | 9 |
| 1983 | 2 |
| 1984 | 9 |
| 1986 | 10 |
| 1987 | 7 |
| 1988 | 3 |
| 1989 | 3 |
| 1990 | 6 |
| 1991 | 14 |
| 1992 | 25 |
| 1993 | 11 |
| 1994 | 7 |
| 1995 | 12 |
| 1996 | 10 |
| 1997 | 8 |
| 1998 | 14 |
| 1999 | 4 |
| 2000 | 4 |
| 2001 | 5 |
| 2002 | 7 |
| 2003 | 11 |
| 2004 | 10 |
| 2005 | 6 |
| 2006 | 8 |
| 2007 | 6 |
| 2008 | 3 |
| 2009 | 4 |
| 2010 | 5 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 9 |
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233790 | ACL TOP 970 CL | JPA | Substantially Equivalent | |
| K230852 | HemosIL Chromogenic Factor IX | GGP | Substantially Equivalent | |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM | JPA | Substantially Equivalent | |
| K223608 | GEM Premier 7000 with IQM3 | CHL | Substantially Equivalent | |
| K223187 | HemosIL Liquid Anti-Xa | QLU | Substantially Equivalent | |
| K231031 | ACL TOP Family 70 Series | GKP | Substantially Equivalent | |
| K223090 | GEM Premier ChemSTAT | CGA | Substantially Equivalent | |
| K223402 | HemosIL von Willebrand Factor Antigen | GGP | Substantially Equivalent | |
| K213464 | HemosIL Liquid Anti-Xa | KFF | Substantially Equivalent | |
| K213426 | HemosIL ReadiPlasTin | GJS | Substantially Equivalent | |
| K203790 | GEM Premier 5000 | CHL | Substantially Equivalent | |
| DEN190032 | HemosIL Liquid Anti-Xa | QLU | Unknown | |
| K200033 | HemosIL von Willebrand Factor Antigen | GGP | Substantially Equivalent | |
| K183555 | GEM Premier ChemSTAT | JFY | Substantially Equivalent | |
| K183549 | GEM Premier ChemSTAT | JGS | Substantially Equivalent | |
| K183546 | GEM Premier ChemSTAT | CGA | Substantially Equivalent | |
| K180486 | HemosIL Factor XII Deficient Plasma | GJT | Substantially Equivalent | |
| K173403 | GEM Premier 5000 | CHL | Substantially Equivalent | |
| K172903 | HemosIL D-Dimer HS 500 | DAP | Substantially Equivalent | |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | LCO | Substantially Equivalent | |
| K170314 | ACL AcuStar | JPA | Substantially Equivalent | |
| K160415 | GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) | GKF | Substantially Equivalent | |
| K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | CHL | Substantially Equivalent | |
| K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | CGA | Substantially Equivalent | |
| K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator | JGS | Substantially Equivalent | |
| K160885 | HemosIL D-Dimer HS | DAP | Substantially Equivalent | |
| K161818 | GEM Premier 3000 | CGA | Substantially Equivalent | |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | LCO | Substantially Equivalent | |
| K160445 | HemosIL Silica Clotting Time | GFO | Substantially Equivalent | |
| K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | GKP | Substantially Equivalent | |
| K150877 | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS | GKP | Substantially Equivalent | |
| K151534 | HemosIL D-Dimer HS | DAP | Substantially Equivalent | |
| K133582 | HEMOSIL D-DIMER HS 500 CONTROL | GGN | Substantially Equivalent | |
| K133005 | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY | GGP | Substantially Equivalent | |
| K132722 | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) | GJS | Substantially Equivalent | |
| K133407 | GEM PREMIER 4000 | CHL | Substantially Equivalent | |
| K122584 | HEMOSIL READIPLAS TIN | GJS | Substantially Equivalent | |
| K112995 | GEM PREMIER 4000 | CEM | Substantially Equivalent | |
| K113211 | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL | GGN | Substantially Equivalent | |
| K110031 | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | GIR | Substantially Equivalent | |
| K110237 | HEMOSIL FACTOR VIII DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K102552 | HEMOSIL LA POSITIVE CONTROL | GGC | Substantially Equivalent | |
| K102164 | HEMOSIL PROTEIN S ACTIVITY ASSAY | GGP | Substantially Equivalent | |
| K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO | CIG | Substantially Equivalent | |
| K091556 | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS | MSV | Substantially Equivalent | |
| K093737 | HEMOSIL F11 & FV DNA CONTROL | NZB | Substantially Equivalent | |
| K092181 | HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS | MID | Substantially Equivalent | |
| K090264 | HEMOSIL D-DIMER HS 500, CONTROLS | DAP | Substantially Equivalent | |
| K090563 | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) | GGN | Substantially Equivalent | |
| K091980 | ACL TOP 700 LAS | GKP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1217183 | 1217183 | INSTRUMENTATION LABORATORY CO. | 180 Hartwell Rd., Bedford, MA 01730 US | 2026 | and 35 more, listed in full below |
| 2431530 | 2431530 | INSTRUMENTATION LABORATORY CO. | 526 Route 303, ORANGEBURG, NY 10962 US | 2026 | and 34 more, listed in full below |
| 3012348571 | 3012348571 | INSTRUMENTATION LABORATORY SPA | Via Leonardo da Vinci, 36, Roncello Lombardy 20877 IT | 2026 | and 33 more, listed in full below |
| 3007719797 | 3007719797 | Instrumentation Laboratory SpA | Zona Industriale Campolungo 327a, 11, Ascoli Piceno Marche 63100 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- CDOAcid, Uric, Uricase (U.V.)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DKBCalibrators, Drug Mixture
- DIHColorimetry, Cholinesterase
- DAKComplement C1q, Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CEMElectrode, Ion Specific, Potassium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- DBTFactor Xiii A, S, Antigen, Antiserum, Control
- DBFFerritin, Antigen, Antiserum, Control
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- CGAGlucose Oxidase, Glucose
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- CISHydrazone Colorimetry, Ast/Sgot
- CZPIga, Antigen, Antiserum, Control
- CZKIga, Rhodamine, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- CGMMethod, Immunodiffusion, Immunoglobulins (G, A, M)
- CIAMethylthymol Blue, Calcium
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- DDRMyoglobin, Antigen, Antiserum, Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- DDXPlasminogen, Antigen, Antiserum, Control
- CIJSaccharogenic, Amylase
- DHRSystem, Test, Rheumatoid Factor
- DDCThyroglobulin, Antigen, Antiserum, Control
- DDGTransferrin, Antigen, Antiserum, Control
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- CDNUrease, Photometric, Urea Nitrogen
- CIEVolumetric/Manometric, Carbon-Dioxide
Recall records
Showing 25 of 104| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2900-2026 | GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A | The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae. | Class II | Open, Classified | |
| Z-2899-2026 | GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. | The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae. | Class II | Open, Classified | |
| Z-2826-2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths. | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management. | Class II | Open, Classified | |
| Z-2825-2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths. | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management. | Class II | Open, Classified | |
| Z-2824-2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths. | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management. | Class II | Open, Classified | |
| Z-2823-2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths. | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management. | Class II | Open, Classified | |
| Z-2822-2026 | Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000. | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management. | Class II | Open, Classified | |
| Z-2821-2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management. | Class II | Open, Classified | |
| Z-1543-2026 | GEM Premier 5000; Part No. 00055445010 & 00055445011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1542-2026 | GEM Premier 5000; Part No. 00055445008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1541-2026 | GEM Premier 5000; Part No. 00055445004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1540-2026 | GEM Premier 5000; Part No. 00055430011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1539-2026 | GEM Premier 5000; Model No. 00055430010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1538-2026 | GEM Premier 5000; Part No. 00055430008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1537-2026 | GEM Premier 5000; Part No. 00055430004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1536-2026 | GEM Premier 5000; Part No: 00055415011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1535-2026 | GEM Premier 5000; Part No. 00055415010. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1534-2026 | GEM Premier 5000; Part No. 00055415008. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1533-2026 | GEM Premier 5000; Part No. 00055415005. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1532-2026 | GEM Premier 5000 PAK; Part No. 00055415004. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1531-2026 | GEM Premier 5000 PAK; Part No. 00055407511. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1530-2026 | GEM Premier 5000 PAK; Part No. 00055407510. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1529-2026 | GEM Premier 5000 PAK; Part No. 00055407508. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1528-2026 | GEM Premier 5000 PAK; Part No. 00055407504. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified | |
| Z-1527-2026 | GEM Premier 5000 PAK; Part No. 00055360011. | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact. | Class II | Open, Classified |
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