Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Luminex Corporation
- Reason for Recall:
- Potential for a false-negative result.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2007-2021
Related Recalls
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Potentially defective utility trays in the reagent kits.