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 20-005-023
    • Cartridge Catalog number 20-006-023
    • Lot 032718023A
    • UDI 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 29, 2020 · Data as of Sep 19, 6:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.