Recall Z-1978-2025— Guangzhou Pluslife Biotech Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Guangzhou Pluslife Biotech Co., Ltd., initiated 2025-01-24. FDA's recall record names no specific 510(k) clearance for this event. 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.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)..
- Recalling firm
- Guangzhou Pluslife Biotech Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-24
- Firm location
- Guangzhou, N/A, China
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.