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ImmunoCard STAT! EHEC
MERIDIAN BIOSCIENCE, INC. · Model 751630 · UDI-DI 00840733101366
GMZ
Prescription
1
510(k) clearances
1
Adverse events (1 deaths)
2
Recalls
10
Facilities
Description
ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.
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.