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OSOM BV Blue 25T Kit
Sekisui Diagnostics, LLC · Model 183 · UDI-DI 00742860100055
MXB
Prescription
2
510(k) clearances
2
Adverse events
1
Recalls
6
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-09 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 De |
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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.