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REMEL EUROPE LIMITED · Model R30165401 · UDI-DI 05056080501062
3
510(k) clearances
1
Adverse events
2
Recalls
4
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-10-20 | BD Diagnostic Systems | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. |
| 2004-10-20 | BD Diagnostic Systems | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. |
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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.