Device product
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Z-0543-2022
Product summary
- Event
- Event 89379
- Status
- Terminated
- Classification
- Class III
- Quantity
- 65 packs (130 units)
- Official record key
device-enforcement:Z-0543-2022
Official wording
Reason: Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
Code information: Catalog Number: 0726P, Lot Number: 726-57-10, UDI: 20845357017486
Distribution pattern: Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.
Derived failure modes
-
Unknown
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.