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Z-1978-2025 Class II Ongoing

Recalled by Guangzhou Pluslife Biotech Co., Ltd. — Guangzhou, N/A

FDA device recall Z-1978-2025 was initiated by Guangzhou Pluslife Biotech Co., Ltd. on January 24, 2025 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 541 units.

Recall Details

Product Type: Devices
Report Date: June 25, 2025
Initiation Date: January 24, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 541 units

Product 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 for Recall

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

Distribution Pattern

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.

Code Information

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