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cobas SARS-CoV-2 Quality Control Kit
Roche Molecular Systems, Inc. · Model 09408835190 · UDI-DI 00875197006759
QWR
Prescription
1
510(k) clearances
152
Adverse events
2
Recalls
5
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-04 | Abbott Diagnostics Scarborough, Inc. | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
| 2025-03-04 | Abbott Diagnostics Scarborough, Inc. | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. |
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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.