Device product
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Z-2533-2024
Product summary
- Event
- Event 94970
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,100 kits
- Official record key
device-enforcement:Z-2533-2024
Official wording
Reason: Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Code information: GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.