FDA Device recall Z-0421-2022
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
- FDA Device
- Class II
- ongoing
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class II recall of FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test by Migo Trading, citing 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 determin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0421-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-04 |
| Published | 2022-01-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Migo Trading |
| Distribution | NY |
Product
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Reason
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.
Identifiers
| code_info | UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0421-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.