Reported Jun 25, 2025 · Ongoing
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version:…
Guangzhou Pluslife Biotech Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Guangzhou Pluslife Biotech Co., Ltd. · Room 402 · Guangzhou, N/A · N/A
Is this the product you have?
- Brand NameMiniDock
- Product NameIntegrated Nucleic Acid
- Testing Device Model/Catalog NumberPM001
- Software VersionN/A
- Product Description1. Product Overview 1.1
- Product NameIntegrated
- Nucleic Acid Testing Device Brand NameMiniDock 1.2
- ModelPM001 2
- Product compositionThis device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging
- ComponentNo
- Lot codes and dates
- Model/Catalog NumberPM001
- Lot numbersAll of the Devices in the U.S
- Amount recalled
- 541 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Guangzhou Pluslife Biotech Co., Ltd. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.