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API® 20 A
BIOMERIEUX SA · Model 20300 · UDI-DI 03573026048150
JSP
Prescription
10
510(k) clearances
64
Adverse events
2
Recalls
8
Facilities
Description
The API 20 A system enables 21 tests to be carried out for ID of anaerobes. Other tests such as colonial and microscopic morphology, Gram stain, etc. to confirm or complete ID
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). |
Query this across every FDA database — by API.
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.