Reported Jul 14, 2021 · Ongoing

Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

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-Positive Blood Culture
  • Nucleic Acid Test (BC-GP) Model Number20-006-018
Lot codes and dates
    • 030620018A
    • 031420018A
    • 032020018A
    • 040120018A
    • 041020018B
    • 041720018B
    • 042420018A
    • 043020018A
    • 050220018A
    • 050720018A
    • 050920018A
    • 051320018A
    • 051420018A
    • 051520018A
    • 052020018A
    • 052120018A
    • 052920018A
    • 060220018A
    • 060920018A
    • 061020018A
    • 061620018A
    • 061920018D
    • 062020018A
    • 062620018A
    • 063020018A
    • 070720018A
    • 071620018A
    • 072320018A
    • 073020018A
    • 080520018A
    • 082020018A
    • 082520018A
    • 082820018A
    • and 090120018A
Amount recalled
36,416

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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 6:16 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.