DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit — Class II medical device recall Z-3307-2024
Ongoing recall by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD, reported 2024-10-09. The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States
| Recall number | Z-3307-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD, Shenzhen, N/A, China |
| Recall initiated | 2024-06-26 |
| Classified | 2024-09-27 |
| Reported by FDA | 2024-10-09 |
| Countries outside the US | CN, HK |
| Quantity | 120,000 kits |
| Model numbers | FAT01 |
Product
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Reason for recall
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
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-3307-2024. 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.