Device product
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Z-0544-2022
Product summary
- Event
- Event 89380
- Status
- Terminated
- Classification
- Class III
- Quantity
- 47 packs (94 units)
- Official record key
device-enforcement:Z-0544-2022
Official wording
Reason: Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Code information: Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.