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ImmunoCard STAT E. coli O157 Plus
MERIDIAN BIOSCIENCE, INC. · Model 750530 · UDI-DI 00840733101816
GMZ
Prescription
1
510(k) clearances
1
Adverse events (1 deaths)
2
Recalls
10
Facilities
Description
The ImmunoCard STAT E. coli O157 Plus is a rapid test for the detection of antigens from Shiga toxin-production E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth of sorbitol MacConkey (SMAC) plates. In the US, ImmunoCard STAT E. coli O157 Plus is not intended for point-of-care use. This device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.
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.