Reported Sep 5, 2018 · Terminated
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria,…
Luminex Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Corporation · 12212 Technology Blvd · Austin, TX · 78727-6101
Is this the product you have?
- Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
- Lot codes and dates
Catalog number 20-005-023Cartridge Catalog number 20-006-023Lot 032718023AUDI 00857573006041
- Amount recalled
- 790 Cartridge Carriers containing 3160 Cartridges
Where it was sold
Why it was recalled
Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).
This product could cause temporary or reversible health problems — stop using it.
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