DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
Recall
- Recall Number
- Z-3306-2024
- Event Number
- 95288
- Firm
- FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China
- FEI Number
- 3016652804
- Product Code
- QYT
- Status
- Open, Classified
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- June 26, 2024
- Posted
- September 27, 2024
Description
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
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 [email protected]. Your prompt attention and adherence to these directives are greatly appreciated as we work together to uphold regulatory compliance and ethical business practices.
International distribution to the countries of China and Hong Kong.
150,000 kits