medical Class II Updated 2024-10-09

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD recalls DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model

Recalled Product

DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01


Hazard / Issue

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

Issued by

FDA

Distribution: International distribution to the countries of China and Hong Kong.
Lot/Code Info: All lots in the United States
View official government recall

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