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Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. Recalls

All product recalls associated with Ortho-Clinical Diagnostics, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Jul 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–55 of 55 recalls

Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products HbA1c Reagent Kit- IVD for the ...

Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis

Moderate

FDAApr 17, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products Calibrator Kit 11 VANC Reagent ...

Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing

Moderate

FDAApr 14, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS XT 7600 Integrated System - For use in the in vitr...

MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

Moderate

1 23

Page 3 of 3Next

FDA

Mar 10, 2023

Nationwide

• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS 5600 Integrated System- For use in the in vitro qu...

MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

Moderate

FDAMar 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N ...

Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results

Moderate

FDAMar 9, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products Intact PTH Reagent Pack-...

Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

Moderate

FDANov 17, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of V...

Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.

Moderate

FDAOct 13, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS XT 7600 Integrated System with Version 3.7.2 and b...

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

Moderate

FDAJul 19, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS XT 3400 Chemistry System with Version 3.7.2 and be...

Moderate

FDAJul 19, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended f...

On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

Moderate

FDAMay 26, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc: VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 19...

Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.

Moderate

FDAMar 25, 2022Nationwide• Ortho-Clinical Diagnostics, Inc

Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products VersaTips, Catalog No. 6801715 ...

Laceration Risk

The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

Moderate

FDADec 10, 2021Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products High Sample Diluent A Re...

Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.

Moderate

FDANov 22, 2021Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Sl...

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

Moderate

FDADec 11, 2020Nationwide• Ortho Clinical Diagnostics Inc

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products Performance Verifier II-For in ...

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

Moderate

FDAOct 16, 2020Nationwide• Ortho Clinical Diagnostics Inc