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cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System
Roche Molecular Systems, Inc. · Model 08160104190 · UDI-DI 00875197005950
10
510(k) clearances
5
Adverse events
5
Recalls
22
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-09 | Abbott Diagnostics Scarborough, Inc. | It was confirmed that the impacted lot has 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. |
| 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. |
| 2024-04-26 | Centers For Disease Control and Prevention | The H5b component may fail to amplify, resulting in an inconclusive result. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially |
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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.