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PREMIER EHEC
MERIDIAN BIOSCIENCE, INC. · Model 608096 · UDI-DI 00840733101724
GNA
Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Description
The Premier EHEC test is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (Verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. coli (EHEC) infections.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-08 | Meridian Bioscience Inc | Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. |
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