Reported Jul 14, 2021 · Ongoing

Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

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 Clostridium difficile Nucleic
  • Acid Test Kit (CDF) Model Number20-006-022
Lot codes and dates
    • 041520022A
    • 061920022A
    • and 081120022A
Amount recalled
1,261

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, 5:35 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.