FDA Enforcement
Class III
Terminated
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Recall: Z-0544-2022
·
Reported February 9, 2022
Enforcement
- Recall Number
- Z-0544-2022
- Event ID
- 89380
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Microbiologics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 9, 2022
- Initiation Date
- February 24, 2021
- Classification Date
- January 31, 2022
- Termination Date
- July 11, 2022
- Address
- 200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States
Description
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Reason
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Code Info
Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Distribution
US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.
Quantity
47 packs (94 units)