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MicroScan

Beckman Coulter, Inc. · Model B1017-2 · UDI-DI 15099590657352

JSP Prescription
1
510(k) clearances
64
Adverse events
2
Recalls
8
Facilities

Description

MicroScan Rapid Anaerobe ID Panel

Recalls

DateFirmReason
2018-03-23BioMerieux SAA 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
2017-04-20Biomerieux IncThe 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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Data 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.