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Wellcolex E.coli O157
REMEL EUROPE LIMITED · Model R30959501 · UDI-DI 05056080501888
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-08 | Meridian Bioscience Inc | Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. |
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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.