Home / Recalls / FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD / Z-3308-2024

Z-3308-2024 Class II Ongoing

Recalled by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD — Shenzhen, N/A

Recall Details

Product Type: Devices
Report Date: October 9, 2024
Initiation Date: June 26, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 50,000 kits

Product Description

DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01

Reason for Recall

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

Distribution Pattern

International distribution to the countries of China and Hong Kong.

Code Information

All lots in the United States