FDA-Device2024-08-14Class II
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Luminex Corporation
Hazard
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Sold states
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.
Affected count
1,100 kits
Manufactured in
4088 Commercial Ave, Northbrook, IL, United States
Products
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2533-2024Don't want to check this manually?
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