Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and Recalled by Luminex Corporation Due to Elevated false positive results Yersinia enterocolitica (Yersinia) from...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Luminex Corporation directly.
Affected Products
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.
Quantity: 790 Cartridge Carriers containing 3160 Cartridges
Why Was This 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).
Where Was This Sold?
Domestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.
About Luminex Corporation
Luminex Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report