Recall archive / FDA device enforcement
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01 — FDA record Z-3306-2024
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 Jun 26, 2024. 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
- DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
- Reason
- The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
- Classification
- Class II
- Recalling firm
- FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
- Quantity
- 150,000 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3306-2024
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 | All lots in the United States |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of China and Hong Kong.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 9, 2024
- Recall initiation date
- Jun 26, 2024
- Center classification date
- Sep 27, 2024
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.