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U.S. Department of Health and Human Services

Class 2 Device Recall DVOT SARSCov2 &Influenza AB Antigen Combo Test Kit

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 Class 2 Device Recall DVOT SARSCov2 &Influenza AB Antigen Combo Test Kitsee related information
Date Initiated by FirmJune 26, 2024
Date PostedSeptember 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3307-2024
Recall Event ID 95288
Product Classification Over-the-Counter COVID-19 Antigen Test - Product Code QYT
ProductDVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Code Information All lots in the United States
Recalling Firm/
Manufacturer		 FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
No. 1304 Science And Technology Innovation Park, Shajing Dahong
Shenzhen China
Manufacturer Reason
for Recall		The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionA 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.
Quantity in Commerce120,000 kits
DistributionInternational distribution to the countries of China and Hong Kong.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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