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ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay
REMEL EUROPE LIMITED · Model R2474096 · UDI-DI 05056080501673
1
510(k) clearances
1
Adverse events (1 deaths)
2
Recalls
10
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-08-21 | Hardy Media Inc Dba Hardy Diag | Performance failure; the product is failing to show pigment development for E. coli 0157. |
| 2002-07-18 | Remel, Inc. | A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plu |
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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.