Z-0543-2022 Class III Terminated
FDA device recall Z-0543-2022 was initiated by Microbiologics Inc on February 24, 2021 and is designated Class III. Reason for recall: Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. The recall status is terminated (terminated July 11, 2022). Affected quantity: 65 packs (130 units).
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- February 24, 2021
- Termination Date
- July 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65 packs (130 units)
Product Description
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Reason for Recall
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
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.
Code Information
Catalog Number: 0726P, Lot Number: 726-57-10, UDI: 20845357017486