FDA recall Z-3306-2024

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-06-26
Report date
2024-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Shenzhen, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3306-2024