US recall of DVOT SARS-Cov-2 and Influenza A+B antigen combo test kits (Model FAT01) due to lack of US authorization. All units sold in the US are affected.
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
The US government has recalled all DVOT SARS-Cov-2 and Influenza A+B antigen combo test kits (Model FAT01) sold in the US because they were not approved for sale in the United States. This means the products could not be legally used for testing in the US market.
The test kits were not approved by US authorities for sale in the United States. This means they do not meet US safety and regulatory standards, which could lead to improper use or potential health risks if used without proper authorization.
All owners of the DVOT SARS-Cov-2 and Influenza A+B antigen combo test kits (Model FAT01) sold in the US are affected. People using these kits for testing may not have legal authorization to use them in the United States.
Check for the model number FAT01 on the DVOT SARS-Cov-2 and Influenza A+B antigen combo test kits. All units sold in the United States are affected by this recall.
Look for the model number FAT01 on the DVOT SARS-Cov-2 and Influenza A+B antigen combo test kits.
The DVOT test kits were not approved by US authorities for sale in the United States.
Check for the model number FAT01 on the DVOT SARS-Cov-2 and Influenza A+B antigen combo test kits. All units sold in the United States are affected.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send FENG CHUN YUAN to request your refund or repair — edit it as you like.
Subject: Recall Z-3307-2024 — FENG CHUN YUAN FENG CHUN YUAN Hello, I own a FENG CHUN YUAN that is covered by recall Z-3307-2024 from FENG CHUN YUAN. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.