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REMEL EUROPE LIMITED · Model R30957201 · UDI-DI 05056080500263
10
510(k) clearances
14
Adverse events
1
Recalls
14
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-25 | Remel Europe Ltd. | Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O seroty |
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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.