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Remel
REMEL, INC. · Model R8311002 · UDI-DI 00848838058035
10
510(k) clearances
64
Adverse events
2
Recalls
8
Facilities
Description
RapID ANA II System 20/KT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-23 | BioMerieux SA | A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux di |
| 2017-04-20 | Biomerieux Inc | The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). |
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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.