Device product
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
Z-0500-2024
Product summary
- Event
- Event 93364
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 222 kits (4,440 trays)
- Official record key
device-enforcement:Z-0500-2024
Official wording
Reason: Potentially defective utility trays in the reagent kits.
Code information: Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.
Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.
Derived failure modes
-
Unknown
Potentially defective utility trays in the reagent kits.