US government recalls DVOT SARS-CoV- 2 & RSV &MP &ADV &FIu A/B Antigen Combo Test Kits (ACT01) due to lack of US authorization. No remedy provided in official notice.
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 RSV antigen combo test kits (model ACT01) because they were not authorized for sale in the United States. This means the products are not legally approved for use in the US market.
The test kits were not approved by the US government for sale in the United States. This means they do not meet US regulatory standards for safety and effectiveness. Using unapproved products could lead to inaccurate results or other risks, though the recall does not specify the exact hazard.
All owners of the DVOT SARS-CoV-2 & RSV &MP &ADV &FIu A/B Antigen Combo Test Kit (model ACT01) in the United States are affected. There is no specific group at higher risk mentioned in the recall.
Check for the model number ACT01 on the DVOT SARS-CoV-2 & RSV &MP &ADV &FIu A/B Antigen Combo Test Kit. The recall applies to all units sold in the United States.
Verify the model number ACT01 on the test kit to confirm it is affected.
The US government has recalled these test kits because they were not authorized for sale in the United States.
The official recall notice does not provide a specific remedy, so no action is required beyond checking if you have the affected model.
The recall does not specify any hazard mechanism, so the risk is unknown.
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-3308-2024 — FENG CHUN YUAN FENG CHUN YUAN Hello, I own a FENG CHUN YUAN that is covered by recall Z-3308-2024 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.
