Recall Z-2576-2023
Microbiologics Inc · initiated August 14, 2023
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Codes / lots: UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024
Reason for recall
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
FDA-determined 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.
Details
- Recall number
- Z-2576-2023
- Initiated
- August 14, 2023
- Posted by FDA
- September 11, 2023
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of MN, PA, TN, TX.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN