BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-1978-2025 · Initiated January 24, 2025

    Recall

    Recall Number
    Z-1978-2025
    Event Number
    96896
    Firm
    Guangzhou Pluslife Biotech Co., Ltd.
    FEI Number
    3037392657
    Product Code
    QKP
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    January 24, 2025
    Posted
    June 13, 2025
    Address
    6 Lianhuayan Road, Room 402, Huangpu, District Guangzhou China

    Description

    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

    Reason

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

    Action

    On January 24, 2025, FORMAL NOTICE REGARDING DISTRIBUTION RESTRICTIONS IN THE U.S. MARKET letters were emailed to distributors. This communication serves to formally notify you that, effective immediately, all authorized distributors of Guangzhou Pluslife Biotech Co., Ltd. are strictly prohibited from marketing, selling, or distributing any Pluslife products to the United States market. In May 2025 an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letters dated May 30, 2025, were sent to the distributor to be sent to consignees. Actions to be taken by the Customer/User: Consumers who still have unused tests manufactured by Pluslife should stop using the device immediately and discard any remaining stock in the trash. - Notice to Distributor: Immediately cease U.S. sales of unauthorized Pluslife devices Issue recall notices to all affected customers in the U.S cooperate fully with the FDA and Pluslife to complete the recall - Company official statement Statement on Prohibition of Unauthorized Sales to the U.S. Market (Published on the Pluslife official website). - Signing the distribution agreement: Prohibiting distributors from selling the unapproved Pluslife products by the FDA in U.S. For assistance, contact: Manufacturer by Pluslife: Marketing Team [email protected] Mon-Fri, 9:00 AM to 6:00 PM CST Distributor by Altruan : After-Sales Team [email protected] Mon-Fri, 9:00 AM to 5:00 PM CET

    Distribution

    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.

    Quantity

    541 units