FDAFDA · Food and drugs·Recall number Z-3307-2024
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Published October 9, 2024 · Recall initiated: June 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
- Distributor
- International distribution to the countries of China and Hong Kong.
- Lot
- All lots in the United States
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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