Roche Diagnostics Operations, Inc. — FDA Enforcement History

FDA action counts

Enforcement history

On 2026-03-11, Argus HQ recorded an FDA recall for Roche Diagnostics Operations, Inc., rated "high" severity in Argus HQ's classification: Roche Diagnostics Operations, Inc. — Class II recall: cobas pro integrated solutions with cobas c 503 analytical units: cobas pro s…. On 2026-01-14, Argus HQ recorded an FDA recall for Roche Diagnostics Operations, Inc., rated "high" severity in Argus HQ's classification: Roche Diagnostics Operations, Inc. — Class II recall: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with s…. On 2024-11-27, Argus HQ recorded an FDA recall for Roche Diagnostics Operations, Inc., rated "high" severity in Argus HQ's classification: Roche Diagnostics Operations, Inc. — Class II recall: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for u…. On 2024-10-02, Argus HQ recorded an FDA recall for Roche Diagnostics Operations, Inc., rated "high" severity in Argus HQ's classification: Roche Diagnostics Operations, Inc. — Class II recall: Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In v…. On 2023-11-29, Argus HQ recorded an FDA recall for Roche Diagnostics Operations, Inc., rated "high" severity in Argus HQ's classification: Roche Diagnostics Operations, Inc. — Class II recall: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Ma…. On 2023-01-18, Argus HQ recorded an FDA recall for Roche Diagnostics Operations, Inc., rated "high" severity in Argus HQ's classification: Roche Diagnostics Operations, Inc. — Class II recall: cobas infinity central lab, Material Number 07154003001. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Roche Diagnostics Operations, Inc. has 6 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

How many FDA actions has Roche Diagnostics Operations, Inc. had?

Argus HQ has recorded 6 FDA events for Roche Diagnostics Operations, Inc.: 0 warning letters, 6 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Roche Diagnostics Operations, Inc.?

The most recent FDA event Argus HQ has on file for Roche Diagnostics Operations, Inc. is dated 2026-03-11, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Roche Diagnostics Operations, Inc. automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Roche Diagnostics Operations, Inc. is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Roche Diagnostics Operations, Inc.?

6 total: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.

Related enforcement actions

• Roche Diagnostics Operations, Inc. — Class II recall: cobas pro integrated solutions with cobas c 503 analytical units: cobas pro s… →
• Roche Diagnostics Operations, Inc. — Class II recall: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with s… →
• Roche Diagnostics Operations, Inc. — Class II recall: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for u… →
• Roche Diagnostics Operations, Inc. — Class II recall: Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In v… →
• Roche Diagnostics Operations, Inc. — Class II recall: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Ma… →
• Roche Diagnostics Operations, Inc. — Class II recall: cobas infinity central lab, Material Number 07154003001 →

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• Roche Diagnostics Operations, Inc. vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.