medical Class II Updated 2018-09-05

Luminex Corporation recalls Verigene Enteric Pathogens Nucleic Acid Test (EP) for detect

Recalled Product

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.

Hazard / Issue

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).

Issued by

FDA

Distribution: Domestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.

Lot/Code Info: Catalog number 20-005-023; Cartridge Catalog number 20-006-023; Lot 032718023A; UDI 00857573006041

View official government recall

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