DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
FDA Recall Z-3306-2024 · Posted 2024-09-27
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Recalling FirmFENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Recall StatusOpen, Classified
Product CodeQYT
Date Initiated2024-06-26
Product Quantity150,000 kits
Reason for Recall
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Firm Action
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
International distribution to the countries of China and Hong Kong.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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