DVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization
The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is classified as an FDA Class II recall with no reported illnesses or injuries. The hazard is the lack of FDA authorization, not a specific documented safety defect. Per the severity rubric, Class II recalls without reported harm are scored as Moderate.
Plain-English summary
The DVOT SARS-CoV-2 Antigen Test Kit, Model FCY-AGT-01, manufactured by Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd, has been recalled from the United States market. This recall involves approximately 150,000 test kits.
The product is subject to this recall because it was not authorized for sale in the United States. The manufacturer did not obtain the necessary FDA authorization to legally distribute this test kit in the U.S. market.
Persons in possession of this test kit should not use it for COVID-19 testing, as the product has not undergone FDA review and approval for safety and effectiveness.
The recalled product
- Product
- DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
- Hazard
- Affected units
- 150,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots in the United States
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
See all →- ModerateDVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization
FDA (Devices) · 2024-10-09
- HighDVOT Rapid Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2024-10-09
Same hazard · unauthorized device
See all →- HighRoyalVibe Unapproved Medical Devices Recalled Due to Lack of FDA Authorization
FDA (Devices) · 2023-10-18
- SevereCOVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization
FDA (Devices) · 2022-05-11
- SevereLuscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2022-03-16
- SevereFDA Recalls COVID-19 Antibody Test Kits for Lacking Regulatory Authorization
FDA (Devices) · 2022-03-16
- SevereFDA Recalls Unauthorized E25Bio COVID-19 Diagnostic Test Kit
FDA (Devices) · 2022-02-16