Guangzhou Pluslife Biotech Co., Ltd.: Device Recall

Recall #Z-1979-2025 · 01/24/2025

Class II: Risk

Recall Details

Recall Number: Z-1979-2025
Classification: Class II
Product Type: Device
Recalling Firm: Guangzhou Pluslife Biotech Co., Ltd.
Status: Ongoing
Date Initiated: 01/24/2025
Location: Guangzhou, N/A, China
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1850 boxes

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).

Product Description

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.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). Component: NO

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.

Other Recalls by Guangzhou Pluslife Biotech Co., Ltd.

Class II: Risk 01/24/2025

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

View all recalls by Guangzhou Pluslife Biotech Co., Ltd. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.