DVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization
The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is regulatory non-compliance (lack of authorization) rather than a confirmed safety defect, consistent with voluntary precautionary recalls.
Plain-English summary
The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) is manufactured by FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD and has not obtained the necessary FDA authorization to be sold in the United States. Approximately 120,000 kits were distributed.
All lots of this product in the United States are subject to this recall. The product was marketed under the DVOT brand but lacks required regulatory approval for sale in the U.S. market.
The recalled product
- Product
- DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
- Affected units
- 120,000
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 Antigen Test Kit Recalled for Lack of 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 medical device
See all →- SevereUnauthorized COVID-19 Diagnostic Test Kits Imported Without FDA Approval
FDA (Devices) · 2022-03-23
- SevereLuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2022-03-16
- SevereCOVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval
FDA (Devices) · 2022-02-09
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