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.

26–50 of 221

  • ModerateFDA (Devices)·Z-0268-2020·2019-11-13

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Cl- Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS chemistry Cl- Slides because the anti-backup platen may fail to advance, causing intermittent slide dispense issues.

    Product
    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0269-2020·2019-11-13

    Ortho-Clinical Diagnostics Recalls VITROS K+ Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS K+ Slides because a mechanical failure may cause intermittent slide dispense issues.

    Product
    VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2180-2019·2019-08-14

    Ortho VITROS 5600 Analyzer Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 89 VITROS 5600 clinical chemistry analyzers worldwide due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 5600 Integrated System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2019·2019-08-14

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products GLU Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products GLU Slides due to potentially biased results.

    Product
    VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 In
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2174-2019·2019-08-14

    Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 30 VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 250 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2175-2019·2019-08-14

    Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling two VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 250 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2019·2019-08-14

    Ortho VITROS 5,1 FS Chemistry System Recalled for Software Calibration Issue

    Ortho Clinical Diagnostics is recalling 55 VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2181-2019·2019-08-14

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 825 VITROS 4600 Chemistry Systems worldwide due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 4600 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2178-2019·2019-08-14

    Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2182-2019·2019-08-14

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling nine VITROS 4600 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 4600 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2185-2019·2019-08-14

    Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2177-2019·2019-08-14

    Ortho VITROS 350 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 30 VITROS 350 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 350 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2179-2019·2019-08-14

    Ortho Clinical Diagnostics Recalls VITROS 5600 Integrated System Analyzers

    Ortho Clinical Diagnostics is recalling 2,531 VITROS 5600 Integrated Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 5600 Integrated System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2019·2019-07-10

    Ortho-Clinical VITROS 350 Chemistry System Recalled for CK Drift

    Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2019·2019-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 250 Chemistry System for CK Drift

    Ortho-Clinical Diagnostics is recalling 5,020 VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase results.

    Product
    VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2019·2019-07-10

    Ortho-Clinical VITROS 250 Chemistry System Recalled for CK Result Drift

    Ortho-Clinical Diagnostics is recalling 2,411 refurbished VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2019·2019-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 250AT Chemistry System

    Ortho-Clinical Diagnostics is recalling 57 VITROS 250AT Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1364-2019·2019-05-29

    Ortho-Clinical VITROS XT 7600 System Recalled for Potential Sample Dispensing Errors

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated Systems because sample fluid may be dispensed to incorrect positions, potentially causing erroneous assay results.

    Product
    VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1288-2019·2019-05-15

    Ortho-Clinical VITROS 5600 Systems Recalled for Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 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-1289-2019·2019-05-15

    Ortho-Clinical VITROS 3600 Immunoassay System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunoassay System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 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-1291-2019·2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 62 VITROS XT 7600 Integrated Systems worldwide because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 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-1287-2019·2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.2 and below due to a luminometer malfunction that may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 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-1290-2019·2019-05-15

    Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunoassay Systems Due to Luminometer Malfunction

    Ortho-Clinical Diagnostics is recalling 28 VITROS 3600 Immunoassay Systems because a luminometer malfunction may prevent the processing of MicroWell assays.

    Product
    VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 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

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.