Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1978-2025·Announced 2025-06-25

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Guangzhou Pluslife Biotech Co., Ltd.
Category: Medical Device — In Vitro Diagnostic / Testing Device
Hazard: unapproved-device
lack-of-premarket-authorization
Affected units: 541

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.

Part of a larger recall action

This product is one of 2 recalled by Guangzhou Pluslife Biotech Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Guangzhou Pluslife Biotech Co., Ltd.

See all →

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