KWIK-STI — Class III medical device recall Z-0546-2022
Terminated recall by Microbiologics Inc, reported 2022-02-09, distributed nationwide. The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly label
| Recall number | Z-0546-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2020-12-16 |
| Classified | 2022-01-31 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2023-01-12 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10845357004083, 70845357028623 |
| Lot numbers | 243-48-5, 8164-78 |
| Model numbers | 0243U, 8164 |
| Expiration dates | 2021-09-30, 2022-07-31 |
Product
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Reason for recall
The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0546-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.