Siemens Healthcare Diagnostics Inc.
Hialeah, FL, US
Siemens Healthcare Diagnostics Inc. appears in FDA device records in Hialeah, FL. FDA records list 1,204 510(k) clearances between and , 581 PMA records and 16 registered establishments. As of , FDA records show 1,478 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
7 namesFDA records resolved to Siemens Healthcare Diagnostics Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Bayer Healthcare, LLC (Diagnostics Division)recall
- Beckman Coulter, Inc.registration, 510(k), PMA, enforcement report, recall
- Dade Behring, Inc.510(k), PMA, recall
- Diagnostic Products Corporation510(k), recall
- Dpc Cirrus510(k), recall
- Siemens Medical Solutions Diagnostics510(k), PMA, enforcement report, recall
- Siemens Microscanrecall
510(k) clearance history
Showing 50 of 1,204FDA records hold 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc. between 1976 and 2026. The busiest year on record is 2006, with 112. The most recent is 2026, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 5 |
| 1978 | 6 |
| 1979 | 5 |
| 1980 | 2 |
| 1981 | 11 |
| 1982 | 12 |
| 1983 | 10 |
| 1984 | 15 |
| 1985 | 7 |
| 1986 | 9 |
| 1987 | 29 |
| 1988 | 13 |
| 1989 | 21 |
| 1990 | 23 |
| 1991 | 13 |
| 1992 | 4 |
| 1993 | 11 |
| 1994 | 16 |
| 1995 | 15 |
| 1996 | 13 |
| 1997 | 17 |
| 1998 | 53 |
| 1999 | 51 |
| 2000 | 69 |
| 2001 | 58 |
| 2002 | 62 |
| 2003 | 42 |
| 2004 | 32 |
| 2005 | 32 |
| 2006 | 112 |
| 2007 | 44 |
| 2008 | 39 |
| 2009 | 46 |
| 2010 | 21 |
| 2011 | 37 |
| 2012 | 14 |
| 2013 | 25 |
| 2014 | 34 |
| 2015 | 22 |
| 2016 | 13 |
| 2017 | 19 |
| 2018 | 10 |
| 2019 | 16 |
| 2020 | 11 |
| 2021 | 7 |
| 2022 | 5 |
| 2023 | 23 |
| 2024 | 24 |
| 2025 | 14 |
| 2026 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253528 | Atellica IM CA 19-9 II | NIG | Substantially Equivalent | |
| K261364 | Atellica CH Acetaminophen 2 (ACTM) | LDP | Substantially Equivalent | |
| K252169 | Access BNP II | NBC | Substantially Equivalent | |
| K254059 | Access anti-HBc IgM | SEI | Substantially Equivalent | |
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | CIG | Substantially Equivalent | |
| K253687 | Access anti-HBc Total | SEI | Substantially Equivalent | |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | JLW | Substantially Equivalent | |
| K251995 | Access anti-HAV IgM | LOL | Substantially Equivalent | |
| K251630 | Atellica IM Total PSA II (tPSAII) | LTJ | Substantially Equivalent | |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | JNL | Substantially Equivalent | |
| K250588 | Access Rubella IgG | LFX | Substantially Equivalent | |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | JZO | Substantially Equivalent | |
| K252580 | iQ200 Series | LKM | Substantially Equivalent | |
| K243846 | Access anti-HAV | LOL | Substantially Equivalent | |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | LTT | Substantially Equivalent | |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | LTT | Substantially Equivalent | |
| K243483 | Access hsTnI | MMI | Substantially Equivalent | |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | LTT | Substantially Equivalent | |
| K242981 | Atellica IM Thyroglobulin (Tg) | MSW | Substantially Equivalent | |
| K242870 | Access hsTnI | MMI | Substantially Equivalent | |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | JLW | Substantially Equivalent | |
| K242022 | Access Toxo IgG | LGD | Substantially Equivalent | |
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer | CGR | Substantially Equivalent | |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | CGX | Substantially Equivalent | |
| K242095 | Access Toxo IgM II | LGD | Substantially Equivalent | |
| K241427 | Access Syphilis | LIP | Substantially Equivalent | |
| K240469 | Access TPO Antibody | JZO | Substantially Equivalent | |
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | MRR | Substantially Equivalent | |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | MMI | Substantially Equivalent | |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | GKZ | Substantially Equivalent | |
| K240996 | Access Thyroglobulin Antibody II | JNL | Substantially Equivalent | |
| K240987 | Access sTfR | DDG | Substantially Equivalent | |
| K240927 | Access Thyroglobulin | MSW | Substantially Equivalent | |
| K241423 | Access Thyroglobulin | MSW | Substantially Equivalent | |
| K240479 | Access OV Monitor | LTK | Substantially Equivalent | |
| K240403 | Access BR Monitor | MOI | Substantially Equivalent | |
| K240800 | Access Intrinsic Factor Ab | LIG | Substantially Equivalent | |
| K240182 | Access EPO | GGT | Substantially Equivalent | |
| K232904 | Access Ostase | CIN | Substantially Equivalent | |
| K232164 | Access NT-proBNP | NBC | Substantially Equivalent | |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | JLW | Substantially Equivalent | |
| K234052 | Access Ferritin | JMG | Substantially Equivalent | |
| K240273 | Access Free T4 | CEC | Substantially Equivalent | |
| K232791 | Access Intact PTH | CEW | Substantially Equivalent | |
| K234005 | Access CK-MB | JHX | Substantially Equivalent | |
| K233480 | Access SHBG | CDZ | Substantially Equivalent | |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | NQD | Substantially Equivalent | |
| K222881 | Access hsTnI | MMI | Substantially Equivalent | |
| K230648 | Access hsTnI | MMI | Substantially Equivalent | |
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | OYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1017835 | 1017835 | BECKMAN COULTER, INC. | 740 WEST 83RD ST., HIALEAH, FL 33014 US | 2026 | and 3 more, listed in full below |
| 1061932 | 3000203293 | BECKMAN COULTER, INC. | 11800 SW 147TH AVE., Miami, FL 33196 US | 2026 | and 37 more, listed in full below |
| 2050010 | 2050010 | BECKMAN COULTER, INC. | 2470 Faraday Ave, CARLSBAD, CA 92010 US | 2026 | and 110 more, listed in full below |
| 2050012 | 2050012 | BECKMAN COULTER, INC. | 250 S Kraemer Blvd, BREA, CA 92821 US | 2026 | and 118 more, listed in full below |
| 2122870 | 2122870 | BECKMAN COULTER, INC. | 1000 LAKE HAZELTINE DR., CHASKA, MN 55318 US | 2026 | and 59 more, listed in full below |
| 3004198394 | 3004198394 | BECKMAN COULTER, INC. | 5350 Lakeview Parkway South Dr, INDIANAPOLIS, IN 46268 US | 2026 | |
| 3002721051 | 3002721051 | Beckman Coulter GmbH | Europark Fichtenhain B 13, Krefeld North Rhine-Westphalia 47807 DE | 2026 | |
| 3007448124 | 3007448124 | Beckman Coulter, Inc | 5355 W. 76th Street, Indianapolis, IN 46268 US | 2026 | |
| 2919016 | 2919016 | Beckman Coulter, Inc. | 1584 Enterprise Blvd, West Sacramento, CA 95691 US | 2026 | and 7 more, listed in full below |
| 3008629785 | 3008629785 | Beckman Coulter, Inc. | 2295 Progress Dr., Hebron, KY 41048 US | 2026 | |
| 2517506 | 2517506 | SIEMENS HEALTHCARE DIAGNOSTICS INC. | 500 GBC DR, PO Box 6101, NEWARK, DE 19714 US | 2026 | and 150 more, listed in full below |
| 3002637618 | 3002637618 | Siemens Healthcare Diagnostics Inc | Point Of Care Headquarters, East Walpole, MA 02032 US | 2026 | and 49 more, listed in full below |
| 1219913 | 1219913 | Siemens Healthcare Diagnostics Inc. | 333 Coney Street, E Walpole, MA 02032 US | 2026 | and 86 more, listed in full below |
| 2432235 | 2432235 | Siemens Healthcare Diagnostics Inc. | 511 Benedict Ave, Tarrytown, NY 10591 US | 2026 | and 237 more, listed in full below |
| 3007494875 | 3007494875 | Siemens Healthcare Diagnostics Inc. | 2150 Stanley Road, Plainfield, IN 46168 US | 2026 | No device listings on this registration |
| 3009448641 | 3009448641 | Siemens Healthcare Diagnostics, Inc. | 430 S Beiger St, Mishawaka, IN 46544 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate
- CGNAcid, Folic, Radioimmunoassay
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- BXXCalibrator, Pressure, Gas
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CEMElectrode, Ion Specific, Potassium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CGZElectrode, Ion-Specific, Chloride
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- BXKGas, Calibration (Specified Concentration)
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- CHNImmunochemical, Ceruloplasmin
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- 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
- CJKPhenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- CDDRadioassay, Vitamin B12
- CKGRadioimmunoassay, Acth
- CJMRadioimmunoassay, Aldosterone
- CIZRadioimmunoassay, Androstenedione
- CGRRadioimmunoassay, Cortisol
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CGCRadioimmunoassay, Gastrin
- CFLRadioimmunoassay, Human Growth Hormone
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- CANRegulator, Pressure, Gas Cylinder
- CJGTetrabromo-M-Cresolsulfonphthalein, Albumin
- CHWTitrimetric With Edta And Indicator, Calcium
- CFOTitrimetric, Magnesium
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
Showing 25 of 1,478| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2974-2026 | Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers | a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected. | Class II | Open, Classified | |
| Z-2973-2026 | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers | a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected. | Class II | Open, Classified | |
| Z-2976-2026 | Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL | Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy. | Class II | Open, Classified | |
| Z-2975-2026 | Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL | Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy. | Class II | Open, Classified | |
| Z-2890-2026 | Atellica CH Urine Albumin REF: 11537225 | processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; and Increased rate of reaction cuvette QC failures and Delayed results due to QC failures. | Class II | Open, Classified | |
| Z-2881-2026 | Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL | out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated. | Class III | Open, Classified | |
| Z-2880-2026 | Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL | Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated. | Class III | Open, Classified | |
| Z-2889-2026 | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." | Class II | Open, Classified | |
| Z-2888-2026 | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." | Class II | Open, Classified | |
| Z-2703-2026 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. | Class II | Open, Classified | |
| Z-2398-2026 | Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay | A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. | Class II | Open, Classified | |
| Z-2005-2026 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; | Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter. | Class II | Open, Classified | |
| Z-1980-2026 | Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. | Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results | Class II | Open, Classified | |
| Z-1922-2026 | Access Total T4 Calibrator, Catalog No. 33805 | Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications. | Class II | Open, Classified | |
| Z-1657-2026 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; | A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes. | Class II | Open, Classified | |
| Z-1484-2026 | Atellica CH Urine Albumin (UAlb). Material Number: 11537225 | Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL. | Class II | Open, Classified | |
| Z-1235-2026 | CellMek SPS Sample Preparation System, REF: C44603, with software | Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management. | Class II | Open, Classified | |
| Z-1026-2026 | Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results. | Class II | Open, Classified | |
| Z-1025-2026 | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results. | Class II | Open, Classified | |
| Z-1221-2026 | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent. | Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. | Class II | Open, Classified | |
| Z-0889-2026 | Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901 | It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results. | Class II | Open, Classified | |
| Z-0493-2026 | Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4; | The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge. | Class II | Open, Classified | |
| Z-0492-2026 | 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6; | The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge. | Class II | Open, Classified | |
| Z-0491-2026 | IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; | The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge. | Class II | Open, Classified | |
| Z-0429-2026 | Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer | An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain