CLASS II ONGOING Device recall · Reported 25 Jun 2025 · FDA Enforcement Report

MiniDock Integrated Nucleic Acid Testing Device recalled

Guangzhou Pluslife Biotech is recalling MiniDock Integrated Nucleic Acid Testing Device, distributed nationwide in the US. The recall was initiated on 24 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: PM001; Lot numbers: All of the Devices in the U.S.

Quantity recalled541 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1978-2025
FDA event ID: 96896
Recalling firm: Guangzhou Pluslife Biotech, Guangzhou, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jan 2025
FDA classified: 13 Jun 2025
Reported: 25 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

24 Jan 2025	Recall initiated by company
13 Jun 2025	Classified by FDA	+140 days
25 Jun 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

Where it was distributed

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Hong Kong, Australia, Singapore, Palestine, Russia, Ecuador, Papua New Guinea, Indonesia, South Africa, Zimbabwe, Brazil, Tunisia, Samoa, Algeria, Romania, Czech Republic, Thailand, South Korea, Malaysia, Fiji, Nepal, Peru, Mexico, Bahamas, Chile, India, Germany, France, Portugal, Vietnam, Spain, Poland, Latin American Region, Italy, Cameroon, Slovakia, Greece, Hungary Bahrain, Estonia, and Ukraine.

Nationwide

Questions about this recall

Why was it recalled?

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Which lots are affected?

Model/Catalog Number: PM001; Lot numbers: All of the Devices in the U.S.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96896

This product is part of a recall event; the main page for the event is Pluslife Sars-CoV-2 Card Sars-CoV-2 Nucleic Acid Testing Card recalled.

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025	CLASS II	Pluslife Sars-CoV-2 Card Sars-CoV-2 Nucleic Acid Testing Card recalled	Guangzhou Pluslife Biotech	Device Malfunction	Nationwide

More recalls from Guangzhou Pluslife Biotech

All 2

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025Device	CLASS II	Pluslife Sars-CoV-2 Card Sars-CoV-2 Nucleic Acid Testing Card recalled	Guangzhou Pluslife Biotech	Device Malfunction	Nationwide

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