Recall archive / FDA device enforcement
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked — FDA record Z-0945-2022
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 Jan 9, 2022. 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), CE marked
- Reason
- Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.
- Classification
- Class II
- Recalling firm
- Acon Biotech (Hangzhou) Co., Ltd.
- Quantity
- 303,760
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0945-2022
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 | Lots: COV1080201, COV1105014 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: MD, PA International Distribution to countries of: Hungary and China.
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
- Apr 27, 2022
- Recall initiation date
- Jan 9, 2022
- Center classification date
- Apr 15, 2022
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.