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MicroScan
Beckman Coulter, Inc. · Model D18447 · UDI-DI 15099590799014
10
510(k) clearances
298
Adverse events
7
Recalls
11
Facilities
Description
MicroScan Pos Combo 50
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-03 | Oxoid Australia Pty Limited | Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguou |
| 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 |
| 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 |
| 2017-10-11 | Biomerieux Inc | Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in associa |
| 2017-08-25 | Biomerieux Inc | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240 |
| 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.