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Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics Recalls

All product recalls associated with Ortho-Clinical Diagnostics.

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Recall Summary

Total Recalls

970

Past Year

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 741–760 of 970 recalls

Ortho-Clinical Diagnostics: VITROS Chemistry Products GLU DT Slides GEN 56, REF (Cata...

Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.

FDASep 27, 2006Nationwide• Ortho-Clinical Diagnostics

Mega Diagnostics: Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CT...

Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product.

FDASep 20, 2006Nationwide• Mega Diagnostics

Mega Diagnostics: Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packa...

Potential for microorganism growth in the alcohol standard.

FDASep 20, 2006Nationwide

1...36 373839 40...49

Page 38 of 49Next

• Mega Diagnostics

Roche Diagnostics Corp.: Roche Elecsys Folate II for use on Elecsys 210 Analyzers;...

Gel-like particle formation; may result in a clot settling in the analyzer measuring cell, which will create a low signal and may cause incorrectly high or low QC and/or patient results depending on the assay method.

FDASep 15, 2006Nationwide• Roche Diagnostics Corp.

Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila: Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold...

Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.

FDASep 8, 2006Nationwide• Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila

Bayer Healthcare, LLC (Diagnostics Division): ADVIA 1650 Chemistry System, Automated Clinical Chemistry...

Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%. Investigation into this issue was initiated promptly following receipt of this complaint.

FDASep 8, 2006PR• Bayer Healthcare, LLC (Diagnostics Division)

Bayer Healthcare, LLC (Diagnostics Division): ADVIA 2400 Chemistry System, Automated Clinical Chemistry...

FDASep 8, 2006PR• Bayer Healthcare, LLC (Diagnostics Division)

Bayer Healthcare, LLC (Diagnostics Division): ADVIA 1200 Chemistry System, Automated Clinical Chemistry...

FDASep 8, 2006PR• Bayer Healthcare, LLC (Diagnostics Division)

Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila: Abbott AxSYM system FSH Master Calibrators (LN 7A60-30),...

Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.

FDASep 7, 2006PR• Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila

Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila: Architect FSH Calibrators (LN 6C24-01), for in vitro diag...

FDASep 7, 2006PR• Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila

Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila: FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.

FDASep 7, 2006PR• Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila

Diagnostic Chemicals, Ltd.: Microalbumin Multi-Calibrator Set, in vitro diagnostic. ...

Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct

FDASep 6, 2006Nationwide• Diagnostic Chemicals, Ltd.

Siemens Healthcare Diagnostics: ADVIA Centaur CP System, Automated Immunoassay Analyzer, ...

Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID) field is left blank

FDAAug 4, 2006Nationwide• Siemens Healthcare Diagnostics

Roche Diagnostics Corp.: Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; ...

The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)

FDAJul 25, 2006Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi K Electrode, a potassium electrode for use ...

Expired product (dated 2006.06) was shipped as replacement for recalled product.

FDAJul 21, 2006Nationwide• Roche Diagnostics Corp.

Louisville Apl Diagnostics Inc: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in v...

Product mislabeled; outer container labeled with incorrect lot number.

FDAJul 18, 2006IN• Louisville Apl Diagnostics Inc

Diagnostica Stago, Inc.: Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal P...

Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

FDAJul 18, 2006Nationwide• Diagnostica Stago, Inc.

Roche Diagnostics Corp.: Roche MagNA Pure LC System (RMD); Catalog no. 03670325001...

If the user opens the instrument lid during decontamination, the cycle will stop, but the timer will continue, resulting in the user believing the instrument has been decontaminated when it has not .

FDAJul 17, 2006Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche MagNA Pure LC Instrument Kit; Catalog no. 122369310...

If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.

FDAJul 17, 2006Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche/Hitachi K Electrode, a potassium electrode for use ...

A design change in the electrodes will result in incorrect potassium level results.

FDAJul 14, 2006Nationwide• Roche Diagnostics Corp.