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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

1000

Past Year

304

Class I (Serious)

Most Recent

Nov 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 501–520 of 4747 recalls

VITROS 5600 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS 4600 System (Ortho) – QC Baseline Defect (2024)

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS XT 7600 System (Ortho) – QC Baseline Defect (2024)

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Page 26 of 238Next

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Nortrel Tablets (Teva) – Tablet Discoloration (2024)

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Class IIILow

FDAJan 25, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Nortrel 7/7/7 Tablets (Teva) – Tablet Discoloration (2024)

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Class IIILow

FDAJan 25, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Pure Care Hand Sanitizer (Alpha Aromatics) – CGMP Deviation (2024)

CGMP Deviations

Class IIModerate

FDAJan 25, 2024IN, MI, NC• Alpha Aromatics

ADVIA Centaur EPO Assay (Siemens) – Result Bias (2024)

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

FDAJan 24, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica IM EPO Assay (Siemens) – Result Bias (2024)

FDAJan 24, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

VITROS 5600 Integrated System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS XT7600 Integrated System (Ortho-Clinical) – Sample Aspiration Risk (2024)

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.