Reported Jul 14, 2021 · Ongoing

Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

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 · 4088 Commercial Ave · Northbrook, IL · 60062-1829

Is this the product you have?

  • Verigene Enteric Pathogens
  • Nucleic Acid Test (EP) Model Number20-006-023
Lot codes and dates
    • 030420023A
    • 031720023A
    • 032520023A
    • 040820023B
    • 041520023B
    • 042220023B
    • 042820023A
    • 050120023A
    • 050620023B
    • 050820023B
    • 052720023A
    • 052820023A
    • 060420023A
    • 060620023A
    • 061120023A
    • 061820023A
    • 062520023A
    • 062720023A
    • 070220023A
    • 070920023A
    • 071420023A
    • 071720023A
    • 072820023A
    • 080420023A
    • and 090920023A
Amount recalled
24,338

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

Potential for a false-negative result.

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

Data as of Sep 19, 5:40 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.