U.S. government recalls DVOT SARS-CoV-2 antigen test kits (model FCY-AGT-01) due to lack of U.S. authorization. All units sold in the U.S. are affected.
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
The U.S. government has recalled all DVOT SARS-CoV-2 antigen test kits (model FCY-AGT-01) sold in the United States because they were not authorized for sale in the U.S. This means the products are not legally approved for use here, so they may not be safe or reliable.
The test kits were not approved by U.S. authorities for sale in the United States. This means they may not meet safety or accuracy standards required for medical devices in the U.S. Using unapproved products could lead to unreliable test results.
All owners of DVOT SARS-CoV-2 antigen test kits (model FCY-AGT-01) sold in the U.S. are affected. People using these kits for testing may not get accurate results due to lack of U.S. authorization.
Check for the model number FCY-AGT-01 on the DVOT SARS-CoV-2 antigen test kit. All units sold in the United States are included in this recall.
Look for the model number FCY-AGT-01 on the DVOT SARS-CoV-2 antigen test kit.
The U.S. government has not approved these test kits for sale in the United States, so they may not be safe or reliable.
The recall does not specify a stop-use instruction, but since they are unapproved, it's recommended to avoid using them for testing.
The recall record does not mention any remedy or replacement options.
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-3306-2024 — FENG CHUN YUAN FENG CHUN YUAN Hello, I own a FENG CHUN YUAN that is covered by recall Z-3306-2024 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.
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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.
