Luminex Recalls Verigene Enteric Pathogens Test Cartridges Due to False Positives
Luminex is recalling Verigene Enteric Pathogens Nucleic Acid Test Cartridges because they may produce elevated false positive results for Yersinia enterocolitica.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score when no hospitalizations or serious injuries are reported, fitting the criteria for minor labeling errors or low-risk contamination issues.
Plain-English summary
Luminex Corporation is recalling the Verigene Enteric Pathogens Nucleic Acid Test (EP) Cartridges, catalog number 20-006-023. The recall involves 790 Cartridge Carriers containing 3,160 Cartridges, specifically Lot 032718023A. These cartridges are components of the Verigene EP Nucleic Acid Test Kit (catalog number 20-005-023), which is used to detect and identify pathogenic enteric bacteria, viruses, and genetic virulence markers from stool samples.
The recall was initiated due to elevated false positive results for Yersinia enterocolitica (Yersinia) reported by customers using the affected cartridges. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The affected products were distributed domestically in Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, and Wisconsin. Users should stop using the affected cartridges and contact Luminex Corporation for further instructions or a replacement.
The recalled product
- 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 gastrointesti
- Manufacturer
- Luminex Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog number 20-005-023
- Cartridge Catalog number 20-006-023
- Lot 032718023A
- UDI 00857573006041
Distribution
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