Device product
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Z-2576-2023
Product summary
- Event
- Event 92878
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2576-2023
Official wording
Reason: One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
Code information: UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024
Distribution pattern: US Nationwide distribution in the states of MN, PA, TN, TX.
Derived failure modes
-
Unknown
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.