FDAFDA · Food and drugs·Recall number Z-2533-2024
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Published August 14, 2024 · Recall initiated: June 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Luminex Corporation
- Distributor
- US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.
- Lot
- GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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