Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US
ORTHO-CLINICAL DIAGNOSTICS, INC. appears in FDA device records in Rochester, NY. FDA records list 311 510(k) clearances between and , 220 PMA records and 12 registered establishments. As of , FDA records show 378 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Ortho-Clinical 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.
- Diagnostic Hybrids, Inc.510(k), enforcement report, recall
- Quidel Corporationregistration, 510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 311FDA records hold 311 510(k) clearances for Ortho-Clinical Diagnostics, Inc. between 1983 and 2025. The busiest year on record is 1999, with 21. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 4 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 9 |
| 1989 | 8 |
| 1990 | 6 |
| 1991 | 9 |
| 1992 | 4 |
| 1993 | 2 |
| 1994 | 3 |
| 1995 | 9 |
| 1996 | 7 |
| 1997 | 15 |
| 1998 | 9 |
| 1999 | 21 |
| 2000 | 8 |
| 2001 | 6 |
| 2002 | 9 |
| 2003 | 10 |
| 2004 | 16 |
| 2005 | 7 |
| 2006 | 21 |
| 2007 | 13 |
| 2008 | 7 |
| 2009 | 12 |
| 2010 | 5 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 14 |
| 2014 | 8 |
| 2015 | 4 |
| 2016 | 8 |
| 2017 | 10 |
| 2018 | 6 |
| 2019 | 5 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 3 |
| 2023 | 10 |
| 2024 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | MMI | Substantially Equivalent | |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | LIP | Substantially Equivalent | |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | DHA | Substantially Equivalent | |
| K231795 | QuickVue COVID-19 Test | QYT | Substantially Equivalent | |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | PGI | Substantially Equivalent | |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | QVF | Substantially Equivalent | |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | CEW | Substantially Equivalent | |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | DHX | Substantially Equivalent | |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | NIG | Substantially Equivalent | |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | QVP | Unknown | |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | QVP | Unknown | |
| K230349 | Lyra RSV+hMPV Assay | OEM | Substantially Equivalent | |
| DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | QVF | Unknown | |
| K230236 | Lyra Influenza A+B Assay | OZE | Substantially Equivalent | |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | LTK | Substantially Equivalent | |
| K213626 | VITROS AFP | LOJ | Substantially Equivalent | |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | JHX | Substantially Equivalent | |
| K211342 | Sofia 2 Campylobacter FIA | LQP | Substantially Equivalent | |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | NBC | Substantially Equivalent | |
| K210858 | VITROS Chemistry Products PHBR Slides | DLZ | Substantially Equivalent | |
| K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators | PMT | Substantially Equivalent | |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | CIX | Substantially Equivalent | |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | CIG | Substantially Equivalent | |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | CGA | Substantially Equivalent | |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | CHH | Substantially Equivalent | |
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | CDN | Substantially Equivalent | |
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | CGZ | Substantially Equivalent | |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | JFY | Substantially Equivalent | |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | LSR | Substantially Equivalent | |
| K181029 | Solana Bordetella Complete Assay | OZZ | Substantially Equivalent | |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | LSR | Substantially Equivalent | |
| K180288 | QuickVue Influenza A+B | PSZ | Substantially Equivalent | |
| K173250 | Solana GBS Assay | NJR | Substantially Equivalent | |
| K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer | GTY | Substantially Equivalent | |
| K163713 | Sofia Lyme FIA, Sofia Lyme Control Set | LSR | Substantially Equivalent | |
| K171974 | Solana RSV+hMPV Assay | OCC | Substantially Equivalent | |
| K163433 | VITROS Chemistry Products GLU Slides | CGA | Substantially Equivalent | |
| K160712 | VITROS Chemistry Products hsCRP Reagent | DCK | Substantially Equivalent | |
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | JIT | Substantially Equivalent | |
| K170491 | Solana C. difficile Assay | OZN | Substantially Equivalent | |
| K162438 | Sofia Influenza A+B FIA on Sofia 2 | PSZ | Substantially Equivalent | |
| K162911 | Sofia RSV FIA on Sofia 2 analyzer | GQG | Substantially Equivalent | |
| K162020 | VITROS Chemistry Products Cl- Slides | CGZ | Substantially Equivalent | |
| K162451 | Solana HSV 1+2/VZV Assay | PGI | Substantially Equivalent | |
| K162274 | Solana Strep Complete Assay | PGX | Substantially Equivalent | |
| K160495 | VITROS® Automation Solutions | KLI | Substantially Equivalent | |
| K161814 | Solana Influenza A+B Assay | OCC | Substantially Equivalent | |
| K161182 | Solana Trichomonas Assay | OUY | Substantially Equivalent | |
| K161140 | VITROS Chemistry Products Calibrator Kit 3 | JIX | Substantially Equivalent | |
| K153012 | Sofia Influenza A+B FIA | PSZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1319681 | 1000136573 | ORTHO-CLINICAL DIAGNOSTICS, INC. | 100 Indigo Creek Dr, Rochester, NY 14626 US | 2026 | and 127 more, listed in full below |
| 1319808 | 1000305841 | ORTHO-CLINICAL DIAGNOSTICS, INC. | 1000 LEE RD., Rochester, NY 14606 US | 2026 | and 43 more, listed in full below |
| 1319809 | 1000305840 | ORTHO-CLINICAL DIAGNOSTICS, INC. | 513 Technology Blvd., ROCHESTER, NY 14626 US | 2026 | and 40 more, listed in full below |
| 2250051 | 2250051 | ORTHO-CLINICAL DIAGNOSTICS, INC. | 1001 US Highway 202, RARITAN, NJ 08869 US | 2026 | and 114 more, listed in full below |
| 3012963943 | 3012963943 | Ortho Clinical Diagnostics, K.K. | Harumi Prime Square 15F, 2-1-40, Harumi, Chuo-ku Tokyo 104-0053 JP | 2026 | and 103 more, listed in full below |
| 3007111389 | 3007111389 | Ortho-Clinical Diagnostics | Felindre Meadows, Pencoed Bridgend CF35 5PZ GB | 2026 | and 40 more, listed in full below |
| 3002642396 | 3002642396 | Ortho-Clinical Diagnostics Singapore Pte Ltd | 27 International Business Park, Singapore South West S609924 SG | 2026 | and 104 more, listed in full below |
| 1528450 | 1000122536 | Ortho-Clinical Diagnostics, Inc. | 2005 East State Street, Suite 100, ATHENS, OH 45701 US | 2026 | and 37 more, listed in full below |
| 3012466784 | 3012466784 | Ortho-Clinical Diagnostics, Inc. | 6005 Freeport Avenue, Suite 130, Memphis, TN 38141 US | 2026 | No device listings on this registration |
| 3021090658 | 3021090658 | Ortho-Clinical Diagnostics, Inc. | 2285 Rutherford Road, Carlsbad, CA 92008 US | 2026 | and 11 more, listed in full below |
| 3033751096 | 3033751096 | Ortho-Clinical Diagnostics, Inc. | 9975 Summers Ridge Rd, San Diego, CA 92121 US | 2026 | and 10 more, listed in full below |
| 2024674 | 2024674 | QUIDEL CORP. | 10165 MCKELLAR CT., SAN DIEGO, CA 92121 US | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- DCFAlbumin, Antigen, Antiserum, Control
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DIHColorimetry, Cholinesterase
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- DAKComplement C1q, Antigen, Antiserum, Control
- CZYComplement C1s, Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- DAEComplement C9, Antigen, Antiserum, Control
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CEMElectrode, Ion Specific, Potassium
- CGZElectrode, Ion-Specific, Chloride
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DISEnzyme Immunoassay, Barbiturate
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- DBFFerritin, Antigen, Antiserum, Control
- CGAGlucose Oxidase, Glucose
- DADHaptoglobin, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- DGOIge, Peroxidase, Antigen, Antiserum, Control
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- DDRMyoglobin, Antigen, Antiserum, Control
- 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
- CDDRadioassay, Vitamin B12
- CGRRadioimmunoassay, Cortisol
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- CDPRadioimmunoassay, Total Triiodothyronine
- CIWStarch-Dye Bound Polymer, Amylase
- DHXSystem, Test, Carcinoembryonic Antigen
- DHASystem, Test, Human Chorionic Gonadotropin
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- DHRSystem, Test, Rheumatoid Factor
- DDGTransferrin, Antigen, Antiserum, Control
- CDNUrease, Photometric, Urea Nitrogen
- DGRWhole Human Serum, Antigen, Antiserum, Control
Recall records
Showing 25 of 378| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2169-2026 | QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. | Product has the potential for false positive results | Class II | Open, Classified | |
| Z-2560-2025 | VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests. | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024. | Class II | Open, Classified | |
| Z-2559-2025 | Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests. | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024. | Class II | Open, Classified | |
| Z-2335-2025 | VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; | Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention. | Class II | Open, Classified | |
| Z-2545-2025 | QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC | Dipstick strep A test has potential for false positive results. | Class II | Open, Classified | |
| Z-2073-2025 | VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests. | Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results. | Class II | Open, Classified | |
| Z-2123-2025 | VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides); | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias). | Class II | Open, Classified | |
| Z-2122-2025 | VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides); | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias). | Class II | Open, Classified | |
| Z-2121-2025 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias). | Class II | Open, Classified | |
| Z-2120-2025 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias). | Class II | Open, Classified | |
| Z-2040-2025 | Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer. | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results. | Class II | Open, Classified | |
| Z-2039-2025 | Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer. | a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results. | Class II | Open, Classified | |
| Z-2038-2025 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915 | A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results. | Class II | Open, Classified | |
| Z-1876-2025 | VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides. | Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label. | Class II | Open, Classified | |
| Z-1948-2025 | Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component | It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay. | Class II | Open, Classified | |
| Z-1007-2025 | Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component | The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument. | Class II | Open, Classified | |
| Z-1006-2025 | Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component | The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument. | Class II | Open, Classified | |
| Z-1005-2025 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component | The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument. | Class II | Open, Classified | |
| Z-0535-2025 | VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740 | May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again. | Class II | Open, Classified | |
| Z-2684-2024 | The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a polyester support. For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromocresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample. Model/Catalog Number: 6844293 | The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue. | Class II | Open, Classified | |
| Z-2580-2024 | VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 | It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results. | Class II | Open, Classified | |
| Z-2266-2024 | VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit. | VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides. | Class II | Open, Classified | |
| Z-2245-2024 | VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Model/Catalog Number: 6802344 | Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately. | Class III | Open, Classified | |
| Z-2019-2024 | VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of vitamin B12 - Product Code: 6800872 | The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required. | Class III | Open, Classified | |
| Z-1637-2024 | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests | There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result. | Class II | Open, Classified |
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