Class II
Medical Device Recall: Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Luminex Corporation · June 20, 2024
Reason for Recall
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
1,100 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2533-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.