FDA Device recall Z-0543-2022
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack
- FDA Device
- Class III
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class III recall of KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack by Microbiologics, citing potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0543-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-02-24 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | GA, MS, MT, NC, NM, NV, TN, TX, WA, WI |
Product
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.
Identifiers
| code_info | Catalog Number: 0726P, Lot Number: 726-57-10, UDI: 20845357017486 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0543-2022%22
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