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.

151–175 of 221

  • ModerateFDA (Devices)·Z-1519-2014·2014-05-07

    Ortho-Clinical Diagnostics Recalls VITROS Specialty Diluent Due to Inaccurate CRP Results

    Ortho-Clinical Diagnostics is recalling VITROS Specialty Diluent because it may cause C-Reactive Protein test results to be approximately 51% lower than expected.

    Product
    VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1520-2014·2014-05-07

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Diluent Packs Due to Inaccurate Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Diluent Pack 3 because internal testing found it may cause C-Reactive Protein test results to be approximately 51% lower than expected when used for dilution.

    Product
    VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1490-2014·2014-04-30

    Ortho-Clinical VITROS Chemistry Calibration Data Module Recalled for Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM No. 0168 because it lacks calibration parameters for DT CRSC slides, preventing system calibration.

    Product
    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1470-2014·2014-04-23

    Ortho-Clinical Diagnostics Recalls VITROS Carbamazepine Slides Due to Potential Bias

    Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides, Lot 3920-0080-8403, because they may produce biased carbamazepine results.

    Product
    VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS an
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1226-2014·2014-03-26

    Ortho-Clinical VITROS White Correction Factor Slides Recalled for Labeling Error

    Ortho-Clinical Diagnostics is recalling VITROS White Correction Factor Slides because an incorrect assay value was printed on the carton, which may delay reporting of specific test results.

    Product
    VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1193-2014·2014-03-19

    Ortho-Clinical Diagnostics Recalls VITROS Vitamin D Calibrators for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 25-OH Vitamin D Total Calibrators because they may generate negatively biased results. Users must immediately discontinue use of all current lots.

    Product
    VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1087-2014·2014-03-05

    Ortho VITROS Sodium Slides Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Na+ Slides and Calibrator Kit 2 because they may produce false positive sodium results in serum and plasma samples.

    Product
    VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 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 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1088-2014·2014-03-05

    Ortho VITROS Chemistry Calibrator Kit 2 Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 because it may produce false positive serum and plasma sample results.

    Product
    VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Mixing Cup Arrays

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Mixing Cup Arrays used on VITROS 250 and 350 systems due to an increase in software errors.

    Product
    VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0941-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls enGen Track System Due to Autoverification Anomaly

    Ortho-Clinical Diagnostics issued an urgent product correction for the enGen Track System and enGen Select v5.0 due to an anomaly affecting the autoverification feature and custom rules.

    Product
    enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0942-2014·2014-02-19

    Ortho-Clinical Diagnostics Recalls enGen Track System Software Due to Autoverification Anomaly

    Ortho-Clinical Diagnostics is recalling the enGen Track System software due to an anomaly affecting the autoverification feature and custom rules.

    Product
    enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0817-2014·2014-01-29

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products COCM Reagent

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products COCM Reagent because of inaccurate quality control results. The recall affects 3,342 units distributed worldwide.

    Product
    VITROS Chemistry Products COCM Reagent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2014·2013-12-25

    Ortho-Clinical Diagnostics Recalls VITROS CA 125 II Calibrators

    Ortho-Clinical Diagnostics is recalling VITROS CA 125 II Calibrators due to a positive shift in patient results.

    Product
    VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry CK Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CK Slides due to slide dispense issues. The recall affects 86,503 units distributed worldwide.

    Product
    VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0311-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS dHDL Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS dHDL Slides because slide dispense cartridges may cause dispensing problems.

    Product
    VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0293-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 544 units distributed worldwide.

    Product
    VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Li Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Li Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0294-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry ALB Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry ALB Slides due to slide dispense issues. The recall affects 16,583 units distributed worldwide.

    Product
    VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0326-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides and Slide Dispense cartridges due to slide dispense issues. The recall affects 127,662 units distributed worldwide.

    Product
    VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0315-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS LAC Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS LAC Slides because slide dispense cartridges may cause dispensing issues.

    Product
    VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0298-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slide Dispense cartridges due to slide dispense issues.

    Product
    VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 81,382 units distributed worldwide.

    Product
    VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrate
    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.