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REMEL EUROPE LIMITED · Model R30850601 · UDI-DI 05056080500034
1
510(k) clearances
1
Adverse events
1
Recalls
12
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-10-26 | Beckman Coulter Inc | Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. |
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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.