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Curian Shiga Toxin
MERIDIAN BIOSCIENCE, INC. · Model 760630 · UDI-DI 00840733103308
GMZ
Prescription
1
510(k) clearances
1
Adverse events (1 deaths)
2
Recalls
10
Facilities
Description
The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient’s clinical symptoms and history.
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.