KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
This recall is currently active, issued September 11, 2023. It was issued by Microbiologics Inc.
- Company
- Microbiologics Inc
- Recall Initiated
- August 14, 2023
- Posted
- September 11, 2023
- Recall Number
- Z-2576-2023
- Quantity
- 4 units
- Firm Location
- Saint Cloud, MN
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
Distribution
US Nationwide distribution in the states of MN, PA, TN, TX.
Lot / Code Info
UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024
Root Cause
Packaging process control
Action Taken
Microbiologics issued an Urgent Medical Device Recall notice to its consignees by email on 08/14/2023. The notice explained the problem with the device and requested the consignee either use or discard the product depending on their lab procedures and how this information affects your usage. Contact Microbiologics if replacement kit is needed.