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.
Check against the official notice below — it lists the full affected range.
Luminex Corporation has recalled the Verigene Enteric Pathogens Nucleic Acid Test Kit, specifically the EP Nucleic Acid Test Cartridges (catalog number 20-006-023, lot 032718023A), used to detect and identify pathogenic bacteria, viruses, and genetic markers in stool samples. The recall was initiated because the cartridges were producing elevated false positive results for Yersinia enterocolitica, a type of pathogenic bacteria. A total of 3,160 cartridges in 790 cartridge carriers were distributed across 17 states including Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, and Wisconsin.
The recall record does not specify a remedy or recommended action for consumers who may have been affected by this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: Domestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin. Quantity: 790 Cartridge Carriers containing 3160 Cartridges Lot/code info: Catalog number 20-005-023; Cartridge Catalog number 20-006-023; Lot 032718023A; UDI 00857573006041
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.