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Elecsys BRAHMS PCT
Roche Diagnostics GmbH · Model 10456299190 · UDI-DI 07613336236499
PRI
Prescription
1
510(k) clearances
213
Adverse events
1
Recalls
12
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result |
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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.