FDA recall Z-2533-2024

Luminex Corporation · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-06-20
Report date
2024-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northbrook, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2533-2024