FLOWFLEX SARS-COV-2 Antigen Rapid Test — Class II medical device recall Z-0421-2022
Ongoing recall by Migo Trading LLC, reported 2022-01-05, distributed in NY. Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has
| Recall number | Z-0421-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Migo Trading LLC, Dayton, NV, United States |
| Recall initiated | 2021-11-04 |
| Classified | 2021-12-27 |
| Reported by FDA | 2022-01-05 |
| Distributed | NY |
| Quantity | 200,100 units |
| UPC / GTIN / UDI-DI | 06921756492427 |
| Lot numbers | COV1080232, COV1095004 |
| Expiration dates | 2023-05-13, 2023-09-03 |
Product
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Reason for recall
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.
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-0421-2022. 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.