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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

303

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 1361–1380 of 4747 recalls

Ortho Clinical Diagnostics Inc: VITROS XT Chemistry Products ALB-TP Slides (ALB is not af...

Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

FDADec 15, 2020Nationwide• Ortho Clinical Diagnostics Inc

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products TP Slides- IVD measure total pr...

Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides

FDADec 15, 2020Nationwide• Ortho Clinical Diagnostics Inc

Vasopressin Injection (SCA Pharmaceuticals) – subpotent drug (2020)

Subpotent drug.

Class IIModerate

FDA

1...67 686970 71...238

Page 69 of 238Next

Dec 14, 2020

Nationwide

• SCA Pharmaceuticals, 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

FDADec 11, 2020Nationwide• Ortho Clinical Diagnostics Inc

Auryxia (Akebia Therapeutics) – manufacturing deviation (2020)

CGMP Deviations

Class IIModerate

FDADec 9, 2020Nationwide• Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Hydroxyzine HCl Solution (Morton Grove) – impurity specs (2020)

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

Class IIModerate

FDADec 9, 2020Nationwide• Morton Grove Pharmaceuticals, Inc.

Roche Diagnostics Operations, Inc.: Roche cobas pro integrated solutions (cobas pro ISE, coba...

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

FDADec 8, 2020Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Roche cobas 8000 modular analyzer series (i.e., cobas 800...

FDADec 8, 2020Nationwide• Roche Diagnostics Operations, Inc.

Sodium Chloride Injection (Hikma) – pH Specification Failure (2020)

Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.

Class IIModerate

FDADec 7, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

Lansoprazole ODT 15mg (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specifications

Class IIModerate

FDADec 3, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

Lansoprazole ODT 30mg (Zydus) – Dissolution Failure (2020)

Failed Dissolution Specifications

Class IIModerate

FDADec 3, 2020Nationwide• Zydus Pharmaceuticals (USA) Inc

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - In vitro diagnostic testing o...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer - In vitro diagnostic testing of...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer - In vitro diagnostic testing o...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: CoaguChek XS PST Meters- IVD (Patient Self-Testing) measu...

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

FDADec 2, 2020Nationwide• Roche Diagnostics Operations, Inc.

Medela AG Medical Technology Lattichstrasse 4b Baai Switzerland: Stryker Medela REF 077.0193 AXS Universal Aspiration Tubi...

Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".

FDADec 2, 2020Nationwide• Medela AG Medical Technology Lattichstrasse 4b Baai Switzerland

Roche Diagnostics Operations, Inc.: CoaguChek XS Prof (Professional) Meters- IVD professional...

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

FDADec 2, 2020Nationwide• Roche Diagnostics Operations, Inc.