FDA Enforcement
Class III
Terminated
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Recall: Z-0543-2022
·
Reported February 9, 2022
Enforcement
- Recall Number
- Z-0543-2022
- Event ID
- 89379
- 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 28, 2022
- Termination Date
- July 11, 2022
- Address
- 200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States
Description
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Reason
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
Code Info
Catalog Number: 0726P, Lot Number: 726-57-10, UDI: 20845357017486
Distribution
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.
Quantity
65 packs (130 units)