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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

133

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 41–60 of 133 recalls

Ortho-Clinical Diagnostics, INc.: VITROS XT Chemistry Products TBIL-ALKP Slides

Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

FDAAug 5, 2023Nationwide• Ortho-Clinical Diagnostics, INc.

ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

FDAJun 5, 2023Nationwide• ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom

Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products NT-proBNP II Range Verif...

May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).

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FDAMay 18, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics: VITROS Chemistry Products Calibrator Kit 20-in vitro diag...

Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.

FDAMay 8, 2023Nationwide• Ortho-Clinical Diagnostics

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

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

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

FDAMar 10, 2023Nationwide• 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

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

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

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.

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.

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

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

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).

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.

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.

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.

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

Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products Anti-HBc IgM Controls, P...

Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.

FDAOct 15, 2021AZ, CA, CO +16 more• Ortho-Clinical Diagnostics, Inc.

Ortho Clinical Diagnostics Inc: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quan...

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results

FDASep 10, 2021Nationwide• Ortho Clinical Diagnostics Inc

Ortho-Clinical Diagnostics, INc.: VITROS CoV2 Ag calibrator (Product Code 6199950) - Produ...

Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.

FDAMay 3, 2021Nationwide• Ortho-Clinical Diagnostics, INc.