MiniDock Integrated Nucleic Acid Testing Device Recall
Guangzhou Pluslife Biotech is recalling the MiniDock Integrated Nucleic Acid Testing Device (Model PM001) because it was distributed in the U.S. without required FDA premarket authorization.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall (as stated in the source metadata). The device was distributed without premarket authorization, a regulatory/compliance violation; no illnesses, injuries, or deaths are reported in the source text, making this a precautionary regulatory recall rather than one driven by an actual patient harm hazard.
Plain-English summary
The MiniDock Integrated Nucleic Acid Testing Device (Model PM001), manufactured by Guangzhou Pluslife Biotech Co., Ltd., is being recalled. Approximately 541 units were distributed in the U.S. and internationally without obtaining required FDA premarket authorization, such as 510(k) clearance or a Premarket Approval (PMA).
The device was distributed nationwide in the U.S. and to multiple countries including Hong Kong, Australia, Singapore, Russia, Brazil, India, Germany, France, and others. Because the device lacks required FDA authorization, its safety and effectiveness have not been verified by the agency.
Persons who own or use this device should stop using it and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Pr
- Manufacturer
- Guangzhou Pluslife Biotech Co., Ltd.
- Hazard
- unapproved-device
- lack-of-premarket-authorization
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model/Catalog Number: PM001
- Lot numbers: All of the Devices in the U.S.
Distribution
Distributed nationwide across the United States.
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