Home / Brands / Guangzhou Pluslife Biotech
Guangzhou Pluslife Biotech Recalls
2 recalls on record · June 25, 2025 to June 25, 2025 · Medical Devices
June 25, 2025Medical DevicesFDA
Guangzhou Pluslife Biotech Co., Ltd. recalls Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM101020
Hazard: Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
June 25, 2025Medical DevicesFDA
Guangzhou Pluslife Biotech Co., Ltd. recalls Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Versio
Hazard: Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).