Guangzhou Pluslife Biotech Co., Ltd. is recalling approximately 2,391 units of MiniDock Integrated Nucleic Acid Testing Devices and Pluslife SARS-CoV-2 Nucleic Acid Testing Cards. The recall includes 541 MiniDock devices (Model PM001) and 1,850 boxes of SARS-CoV-2 test kits (Model RM1010202) that were distributed in the U.S. without the required FDA premarket authorization. No injuries or incidents have been reported in connection with these products.
These devices and test kits have not undergone the required FDA review process to verify their safety and performance. Using unauthorized diagnostic tests can lead to incorrect results, which may result in delayed treatment or inappropriate medical decisions.
Quantity: 541 units. Device components include the main unit, power cord, data cable, power adapter, and chip bracket.
Quantity: 1850 boxes. Each kit contains reaction cards, nucleic acid releasing agent, disposable sampling swabs, and waste bags.
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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