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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

1000

Class I (Serious)

34

Most Recent

Jan 2026

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 3281–3300 of 21320 recalls

Tina-quant D-Dimer Test (Roche) – Result Elevation Issue (2023)

Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

FDAOct 3, 2023Nationwide• Roche Diagnostics Operations, Inc.

Edge Biologicals Sterile Water (Edge Biologicals) – Packaging Mislabeling (2023)

Due to product outer packaging incorrectly labeled.

FDAOct 2, 2023Nationwide• Edge Biologicals Inc

EVIS EXERA III Videoscope (Olympus) – Sterilization Failure (2023)

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

FDAOct 2, 2023Nationwide

1...163 164165166 167...1066

Page 165 of 1066Next

• Olympus Corporation of the Americas

ACMI Roller Bar Electrodes (Olympus) – Incorrect Pouch Labeling (2023)

Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

FDAOct 2, 2023AL, FL, GA +10 more• Olympus Corporation of the Americas

Lidocaine Ophthalmic Solution (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Calcium Gluconate Irrigation Solution (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Lidocaine-Oxymetazoline Solution (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Foscarnet Sodium Injection (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Moxifloxacin Intraocular Solution (Pine Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Tropi-Phen Ophthalmic Solution 15mL (Pine Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Endophth Kit (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Cefuroxime Syringe (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Calcium Chloride IV Solution (Pine Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Vancomycin Intraocular Solution (Pine Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Bevacizumab Injection Solution (Pine Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Moxifloxacin Solution (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Lidocaine-Phenylephrine Vial (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

TPC Ophthalmic Drops (Pine Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Calcium Gluconate Inhalation Solution (Pine Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Tropi-Phen Ophthalmic Solution (Pine Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC