Reported Aug 14, 2024 · Ongoing

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

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 (BC-GP) Nucleic Acid Test
Lot codes and dates
  • GTIN Number00840487101575
  • Catalog Number20-006-018
  • Lot Number031824018A
  • Expiration Date09/16/2024
Amount recalled
1,100 kits

Where it was sold

Why it was recalled

Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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

Free recall alerts

Get alerted about new Luminex Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 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.