Reported Jul 14, 2021 · Ongoing

Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

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 Gram Negative Blood Culture
  • Nucleic Acid Test (BC-GN) Model Number20-006-021
Lot codes and dates
    • 030320021B
    • 031220021A
    • 032720021B
    • 040820021A
    • 041020021A
    • 041720021A
    • 042220021A
    • 042920021A
    • 050520021A
    • 051220021A
    • 051920021A
    • 053020021A
    • 060520021A
    • 061220021A
    • 061720021A
    • 070120021A
    • 072420021A
    • 081820021B
    • and 082620021A
Amount recalled
17,110

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, 5:31 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.