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

Recall #Z-3306-2024 · 06/26/2024

Class II: Risk

Recall Details

Recall Number: Z-3306-2024
Classification: Class II
Product Type: Device
Recalling Firm: FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Status: Ongoing
Date Initiated: 06/26/2024
Location: Shenzhen, N/A, China
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 150,000 kits

Reason for Recall

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

Product Description

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

Distribution Pattern

International distribution to the countries of China and Hong Kong.

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

Class II: Risk 06/26/2024

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Class II: Risk 06/26/2024

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

View all recalls by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.