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Luminex Corporation recalls Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Recalled August 14, 2024 · FDA recall Z-2533-2024 · Luminex
Hazard
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets. · FDA Class II
Units
1,100 kits
Sold at
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.
Description
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Product
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Manufacturer(s)
Luminex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →