FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD recalls DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

Recalled October 9, 2024 · FDA recall Z-3306-2024 · FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD

Hazard

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

Units

150,000 kits

Sold at

International distribution to the countries of China and Hong Kong.

Description

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

Product

DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

Manufacturer(s)

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD

Made in

China

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →