Approximately 320,000 DVOT brand rapid test kits for COVID-19, Influenza, RSV, and other viruses are being recalled because they have not obtained the necessary authorization to be sold in the United States. The recall includes the DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01), the SARS-CoV-2 & Influenza A+B Combo Test Kit (Model FAT01), and the multi-virus Antigen Combo Test Kit (Model ACT01). Because these tests were not reviewed by the FDA, their performance and reliability cannot be guaranteed, potentially leading to incorrect results. Consumers should contact their healthcare provider for guidance on retesting and reach out to the manufacturer for instructions on returning the product.
The use of unauthorized test kits poses a risk of false-negative or false-positive results, which can lead to delayed treatment, the unintended spread of illness, or incorrect medical management. No injuries or incidents have been reported, but the FDA considers unauthorized tests to be a moderate risk to public health.
Manufacturer and Healthcare consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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