Z-2576-2023 Class III Ongoing
FDA device recall Z-2576-2023 was initiated by Microbiologics Inc on August 14, 2023 and is designated Class III. Reason for recall: One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis. The recall status is ongoing. Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- August 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Reason for Recall
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
Distribution Pattern
US Nationwide distribution in the states of MN, PA, TN, TX.
Code Information
UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024