DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
This recall is currently active, issued September 27, 2024. It was issued by Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China.
- Recall Initiated
- June 26, 2024
- Posted
- September 27, 2024
- Recall Number
- Z-3306-2024
- Quantity
- 150,000 kits
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
All lots in the United States
Root Cause
Unknown/Undetermined by firm
Action Taken
A Notification letter dated 6/26/24 was sent to customers: To all esteemed exporters and distributors: It has come to our attention that the "DVOT brand" rapid test kits manufactured by our company have not obtained the necessary authorized from the US FDA (EUA & 510K). Consequently, any attempt to sell these products within the United States is in direct violation of legal regulations and carries significant legal liabilities. In light of this, we wish to formally notify you of the following: 1. The sale or distribution of DVOT brand rapid test kits within the territory of the United States is strictly prohibited. Any party found in contravention will face immediate suspension of their supplies, with severe violators facing potential termination of cooperation. 2. For comprehensive details regarding product recalls or related matters, we urge you to contact our dedicated Quality Manager, Romon at romen@fcy-medical.com. Your prompt attention and adherence to these directives are greatly appreciated as we work together to uphold regulatory compliance and ethical business practices.