The Recall Desk

FDA (Devices) recall action 96896

Guangzhou Pluslife Biotech Co., Ltd. recalled 2 products on 2025-06-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-06-25
Critical
0
Units
2,391

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-06-25

    Pluslife SARS-CoV-2 Card Test Kits Recalled for Lack of FDA Authorization

    Pluslife SARS-CoV-2 Card nucleic acid testing kits were distributed in the U.S. without required FDA premarket authorization. The FDA is recalling approximately 1,850 boxes distributed nationwide and internationally.

    Product
    Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2
    Category
    Distribution
    0 states