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MicroScan
Beckman Coulter, Inc. · Model B1017-216 · UDI-DI 15099590657550
20
510(k) clearances
10
Adverse events
39
Recalls
10
Facilities
Description
Pos MIC Panel Type 34
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-05 | Biomerieux Inc | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aerugin |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
| 2016-02-24 | Biomerieux Inc | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. |
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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.