The Recall Desk

Manufacturer

Ortho-Clinical Diagnostics

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

What the numbers show

Total
221
Critical
0
Severe
10
Most recent
2024-04-03

Of the 221 recalls from Ortho-Clinical Diagnostics we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (5%) 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 221

  • ModerateFDA (Devices)·Z-1292-2019·2019-05-15

    Ortho-Clinical VITROS ECi/ECiQ Immunodiagnostic System Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 45 VITROS ECi/ECiQ Immunodiagnostic Systems worldwide due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1293-2019·2019-05-15

    Ortho-Clinical VITROS ECi Immunodiagnostic System Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 25 refurbished VITROS ECi Immunodiagnostic Systems because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2019·2019-05-01

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Software Error

    Ortho-Clinical Diagnostics is recalling 80 VITROS XT 7600 Integrated Systems because a software error may cause incorrect test results without alerting the user.

    Product
    VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0992-2019·2019-03-20

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Na+ Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Na+ Slides because imprecision in the affected lot may produce biased patient sample and quality control fluid results.

    Product
    VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integra
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0848-2019·2019-02-27

    Ortho-Clinical Diagnostics Recalls VITROS VALP Reagent Packs Due to Negative Bias

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products VALP Reagent Packs because they may produce negative bias results when measuring valproic acid.

    Product
    VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent for Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS NT-proBNP Reagent because it may produce biased results at low biotin concentrations.

    Product
    VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS HBeAg Reagent Due to Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.

    Product
    VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0687-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS Anti-HBe Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Packs because biased results may occur at lower biotin concentrations than indicated in the instructions.

    Product
    VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System units due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2019·2018-12-26

    Ortho-Clinical VITROS 5600 Recall for Software Stability Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0651-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may incorrectly extend reagent stability time.

    Product
    VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0653-2019·2018-12-26

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software

    Ortho-Clinical Diagnostics is recalling 728 VITROS 4600 Chemistry Systems because a software anomaly may incorrectly extend reagent stability time.

    Product
    VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0476-2019·2018-11-28

    Ortho-Clinical VITROS dLDL Reagent Recalled for Negatively Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products dLDL Reagent GENs 26 and 27 because the in vitro diagnostic may produce negatively biased results.

    Product
    VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2019·2018-11-14

    Ortho-Clinical Diagnostics Recalls VITROS Vitamin B12 Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Reagent Packs due to a potential for increased calibration failures.

    Product
    VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2019·2018-10-17

    Ortho-Clinical VITROS 5600 System Recalled for Sample Dispensing Defect

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because they may dispense insufficient sample volume without suppressing potentially incorrect results.

    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, Catalog Number: 6802413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2019·2018-10-17

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems

    Ortho-Clinical Diagnostics is recalling refurbished VITROS 5600 Integrated Systems because they may dispense insufficient sample volumes without suppressing potentially incorrect results.

    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, Catalog Number: 6802915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3280-2018·2018-10-10

    Ortho-Clinical VITROS Sodium Slides Recalled for Potential Positively Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Sodium Slides due to a potential for positively biased results. The recall covers multiple generations and expiry dates distributed globally.

    Product
    VITROS Sodium Slides, Catalog # 837 9034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3193-2018·2018-09-26

    Ortho-Clinical VITROS Chemistry CREA Slides Recalled for Measurement Accuracy Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides because they failed to meet accuracy standards for low-end creatinine measurements in serum and urine.

    Product
    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3184-2018·2018-09-26

    Ortho-Clinical VITROS Chloride Slides Recalled for Analytical Performance Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they failed to meet performance standards for urine samples.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3044-2018·2018-09-19

    Ortho-Clinical VITROS Chloride Slides Recalled for Interference Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3043-2018·2018-09-19

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Cl- Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides in serum samples.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2344-2018·2018-07-11

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides due to a potential for imprecise results in quality control and patient samples.

    Product
    VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2018·2018-03-14

    VITROS DAT Performance Verifier I recalled due to labeling issue

    Ortho-Clinical Diagnostics is recalling 349 units of VITROS DAT Performance Verifier I because the storage labeling is incorrect, which may cause lower than expected test results.

    Product
    VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0915-2018·2018-03-14

    Ortho-Clinical VITROS DAT Performance Verifier V Recall for Storage Labeling Issues

    Ortho-Clinical Diagnostics is recalling VITROS DAT Performance Verifier V units due to storage labeling errors that may cause lower than expected VITROS BENZ results.

    Product
    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0913-2018·2018-03-14

    Ortho-Clinical Recalls VITROS DAT Performance Verifier III Due to Labeling Error

    Ortho-Clinical Diagnostics is recalling 180 units of VITROS DAT Performance Verifier III because incorrect storage labeling may cause lower than expected test results.

    Product
    VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
    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.