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

Recall date

June 26, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3306-2024

FDA classification

Class II

Brand / firm

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

Sold / distributed

International distribution to the countries of China and Hong Kong.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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