The Recall Desk

Manufacturer

Ortho-Clinical Diagnostics, INc.

90 recalls in our database name Ortho-Clinical Diagnostics, INc. as the manufacturing or recalling firm.

What the numbers show

Total
90
Critical
0
Severe
1
Most recent
2025-09-24

Of the 90 recalls from Ortho-Clinical Diagnostics, INc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (1%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 90

  • HighFDA (Devices)·Z-1628-2023·2023-05-31

    VITROS Chemistry HbA1c Reagent Kit recalled due to inaccurate test results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry HbA1c Reagent Kits due to potential for false-positive and false-negative results, which may lead to misdiagnosis.

    Product
    VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1557-2023·2023-05-10

    VITROS 5600 Integrated System MicroTip Pack Opener Assembly Defect

    Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.

    Product
    VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1556-2023·2023-05-10

    VITROS 5600 system pack opener assembly may not function properly

    The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.

    Product
    VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnosti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1555-2023·2023-05-10

    VITROS XT 7600 Analyzer Pack Opener May Not Remove Reagent Pack Caps

    The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.

    Product
    VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2023·2023-04-26

    VITROS COVID-19 Antibody Test Calibrators Recalled for Incorrect Calibrator Levels

    Ortho-Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total N Antibody Calibrators used in COVID-19 testing due to incorrect calibrator levels in Assay Data Disks, which can delay patient test results.

    Product
    VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2023·2023-01-11

    VITROS Intact PTH Reagent Pack recalled for negatively biased measurement results

    Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.

    Product
    VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0220-2023·2022-11-16

    Diagnostic Calibrator Kit Recalled for Software Defect Affecting System Calibration

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 9 due to incorrect calibration software (DRVs 6194-6200) that prevents laboratory systems from successfully calibrating, causing delayed test results.

    Product
    VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2022·2022-09-14

    Laboratory diagnostic system may report inaccurate results during shutdown

    The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.

    Product
    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2022·2022-09-14

    VITROS XT 3400 Chemistry System May Produce Inaccurate Test Results

    The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.

    Product
    VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2022·2022-07-20

    Anti-SARS-CoV-2 IgG Reagent: Stability Time Overstated in Instructions

    Ortho-Clinical Diagnostics is recalling Anti-SARS-CoV-2 IgG Quantitative Reagent Pack because the Instructions For Use incorrectly state on-analyzer stability of 8 weeks when the actual supported time is 6 weeks.

    Product
    Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2022·2022-05-25

    FDA Recalls VITROS Immunodiagnostic LH Reagent Pack for measurement imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.

    Product
    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2022·2022-05-25

    VITROS Immunodiagnostic Hormone Reagents Recalled for Measurement Imprecision

    Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.

    Product
    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2022·2022-05-25

    VITROS Prolactin Reagent Recalled for Low-End Measurement Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2022·2022-03-16

    Laboratory diagnostic tips recalled for potential dispensing errors

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry VersaTips due to shape deformity that may reduce sample volume by 16%. Undetected errors could result in inaccurate test results for bloodborne infectious disease assays.

    Product
    VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2022·2022-01-26

    VITROS High Sample Diluent A Reagent Produces Lower Than Expected Results

    Ortho-Clinical Diagnostics is recalling VITROS High Sample Diluent A Reagent Pack Lot 2190 because it produces lower than expected TSH test results. The recall affects 1,416 units distributed worldwide.

    Product
    VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0247-2022·2021-11-24

    VITROS Immunodiagnostic Anti-HBc Controls Recalled Due to Incorrect Booklet Information

    Ortho-Clinical Diagnostics recalled 191 units of VITROS Anti-HBc IgM Controls (Lot 1690) because the Controls Values booklet contained incorrect product information. Although patient test result accuracy is not affected, there is potential for delayed quality control troubleshooting.

    Product
    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0120-2022·2021-10-27

    Diagnostic Control Material Outside Expected Range, Potential for Delayed Results

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Immunodiagnostic Controls that may be outside the expected control range, potentially delaying diagnostic test results in laboratory systems.

    Product
    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2021·2021-06-02

    Ortho VITROS CoV2 Ag Calibrator Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling 74 units of VITROS CoV2 Ag calibrator (Lot 0020) due to potential unexpected calibration failures.

    Product
    VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1489-2021·2021-05-05

    Ortho-Clinical VITROS Black Reference Slides Recalled for Mislabeling

    Ortho-Clinical Diagnostics is recalling VITROS Black Reference Slides incorrectly labeled as White Reference Slides, which may cause analyzer delays.

    Product
    VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1295-2021·2021-03-31

    Ortho-Clinical Diagnostics Recalls VITROS TIBC Calibrator Kits Due to Performance Shift

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 4 and Fe Slides because TIBC results may be approximately 80 ug/dL lower than expected.

    Product
    VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2021·2021-03-24

    Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Recalled for False Results

    Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagents because they may produce false reactive results when used with Remel M4RT Viral Transport Media.

    Product
    VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2021·2021-03-24

    Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Pack Recall for False Results

    Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagent Packs used with Remel M4RT Viral Transport Media due to potential false reactive results.

    Product
    VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2021·2021-03-03

    Ortho-Clinical Recalls Deformed VITROS Chemistry VersaTips

    Ortho-Clinical Diagnostics is recalling deformed VITROS Chemistry VersaTips that may cause assay results to be biased by up to +/-16%.

    Product
    VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips Assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0844-2021·2021-01-20

    Ortho VITROS Chemistry TP Slides Recalled for Eltrombopag Interference

    Ortho Clinical Diagnostics is recalling VITROS Chemistry TP Slides because the drug eltrombopag can interfere with total protein measurements.

    Product
    VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2021·2021-01-20

    Ortho Clinical Diagnostics Recalls VITROS XT Chemistry Products ALB-TP Slides

    Ortho Clinical Diagnostics is recalling VITROS XT Chemistry Products ALB-TP Slides due to potential interference from the drug eltrombopag.

    Product
    VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Ortho-Clinical Diagnostics

in vitro diagnostics company for blood testing

Country
United States
Founded
1994

Official website

Source: Wikidata (Q7104389), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.