Guangzhou Plus: MiniDock Integrated Nucleic Acid Testing Device (PM001) recalled due to lack of FDA premarket authorization. No remedy specified in official notice.
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
The MiniDock Integrated Nucleic Acid Testing Device (model PM001) is being recalled because it was sold in the U.S. without the required FDA premarket authorization. This means the device may not be safe for use as it lacks proper regulatory approval.
The device was distributed without the necessary FDA premarket authorization, which means it has not been proven safe or effective for its intended use. This could lead to potential health risks if used improperly or without proper regulatory oversight.
Users of the MiniDock Integrated Nucleic Acid Testing Device (model PM001) in the U.S. are affected. Those using the device for medical testing without FDA approval are at risk.
Check for the MiniDock brand and model number PM001 on the device. The product was sold in the U.S. market with all units affected.
Identify the model number PM001 on the device to confirm it is affected.
The device was distributed in the U.S. without the required FDA premarket authorization, meaning it lacks proper regulatory approval for safety and effectiveness.
The official recall notice does not specify a remedy, so no action is required beyond checking if you have the affected model.
The recall notice does not describe specific injury risks, so the danger level is unknown.
We’ve drafted a message you can send MiniDock to request your refund or repair — edit it as you like.
Subject: Recall Z-1978-2025 — MiniDock MiniDock Hello, I own a MiniDock that is covered by recall Z-1978-2025 from MiniDock. 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.
