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Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. Recalls

All product recalls associated with Roche Diagnostics Operations, Inc..

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Recall Summary

Total Recalls

1000

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 941–960 of 2399 recalls

Roche Diagnostics Operations, Inc.: Online TDM Vancomycin Gen.3 (100 tests) Catalog # 067793...

Inaccurately Low Sample Results

FDAJul 23, 2019AL, AK, AZ +49 more• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779...

Inaccurately Low Sample Results

FDAJul 23, 2019AL, AK, AZ +49 more• Roche Diagnostics Operations, Inc.

MONSEL'S Solution (Gordon Laboratories) – Microbial Contamination (2019)

Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.

Class IIModerate

FDA

1...46 474849 50...120

Page 48 of 120Next

Jul 19, 2019

Nationwide

• Dercher Enterprises, Inc., DBA Gordon Laboratories

Roche Diagnostics Operations, Inc.: cobas c513 Analyzer

Quality issue with high pressure solenoid valves

FDAJul 18, 2019AK, CA, FL +12 more• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: cobas e 601 module (cobas 6000 Modular Series system) Par...

Quality issue with high pressure solenoid valves may cause inaccurate results.

FDAJul 18, 2019AK, CA, FL +12 more• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Cobas 8000 Modular Analyzer Series: cobas 8000 ISE mod...

Quality issue with high pressure solenoid valves

FDAJul 18, 2019AK, CA, FL +12 more• Roche Diagnostics Operations, Inc.

Tamsulosin Hydrochloride Capsules (Macleods) – Dissolution Failure (2019)

Failed Dissolution Specifications

Class IIModerate

FDAJul 17, 2019Nationwide• Macleods Pharma Usa Inc

Roche Diagnostics Operations, Inc.: Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190

Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.

FDAJul 16, 2019AZ, CA, FL +19 more• Roche Diagnostics Operations, Inc.

Drospirenone Ethinyl Estradiol Tablets (Jubilant Cadista) – Failed Dissolution (2019)

Failed dissolution specifications : failed results at the 3-month stability time point.

Class IHigh

FDAJul 9, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Roche Diagnostics Operations, Inc.: The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno...

The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog number 04580010190), lot number 349860 on the cobas c311 analyzer and cobas c501 and c502 modules due to a drop in signal in the reaction kinetics. This signal drop was traced to an adjacent cell mixing effect. Sample recovery is decreased as a consequence of the disturbance in reaction kinetics. The investigation found discrepancies of up to -30%. Calibration, QC, and patient samples can be affected. The following issues were reported: - Calibration failures; Dup.E error due to signal drop in reaction kinetics - Sporadic quality control (QC) imprecision. As a long-term solution, the firm will implement required extra wash cycles (EWCs) into the respective Special Wash Requirements method sheets for the cobas c 311 analyzer and cobas c 501 and 502 modules, and into the cobas e-file for the cobas c 502 module. For the use of the reagent with the cobas c501 and c502, Roche will also direct users to run the Tina-Quant Myoglobin gen. 2 assay independently from other tests, in a batch mode status, with a maximum of 39 samples per run. Additionally, a change in the application settings of the Tina-quant Myoglobin Gen.2 assay on the cobas c 501 and 502 modules will be implemented so that adjacent cuvettes are no longer used in order to prevent adjacent cell mixing effects. The application settings change will be communicated at a later date.

FDAJul 2, 2019Nationwide• Roche Diagnostics Operations, Inc.

NuVasive Specialized Orthopedics, Inc.: MAGEC 1 System

Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

FDAJun 25, 2019Nationwide• NuVasive Specialized Orthopedics, Inc.