FDA Device recall Z-3307-2024
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
- FDA Device
- Class II
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class II recall of DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01 by Feng Chun Yuan Medical Equipment Shenzhen, citing the "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3307-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-26 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Feng Chun Yuan Medical Equipment Shenzhen |
| Distribution | n/a |
Product
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Reason
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Identifiers
| code_info | All lots in the United States |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3307-2024%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.