Recall archive / FDA device enforcement
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test — FDA record Z-0421-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 4, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Migo Trading LLC
- Quantity
- 200,100 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0421-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
NY
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 5, 2022
- Recall initiation date
- Nov 4, 2021
- Center classification date
- Dec 27, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.