Class II

Medical Device Recall: DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD · June 26, 2024

Reason for Recall

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

Distribution

International distribution to the countries of China and Hong Kong.

Quantity Affected

150,000 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3306-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD Medical Device Recall: DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01 | SafeCheck