Z-3308-2024 Class II Ongoing
FDA device recall Z-3308-2024 was initiated by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD on June 26, 2024 and is designated Class II. Reason for recall: The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States. The recall status is ongoing. Affected quantity: 50,000 kits.
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