DVOT SARS-CoV-2 Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
Brand
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China
Lot Codes / Batch Numbers
All lots in the United States
Products Sold
All lots in the United States
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China is recalling DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01 due to The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026