Recall Z-3306-2024 ยท QYT Over-The-Counter Covid-19 Antigen Test
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
| Date | Sep 27, 2024 (initiated Jun 26, 2024) |
| Status | Open, Classified |
| Reason | The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States. |
| Root cause | Unknown/Undetermined by 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 |
| Quantity | 150,000 kits |
| Distribution | International distribution to the countries of China and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.