Class 2 Device Recall Pluslife SARSCoV2 Card

• Date Initiated by Firm: January 24, 2025
• Date Posted: June 13, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1979-2025
• Recall Event ID: 96896
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: 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
• Code Information: Model/Catalog Number: RM1010202; Lot numbers: All lots of the COVID-19 test kits in the U.S.
• Recalling Firm/ Manufacturer: Guangzhou Pluslife Biotech Co., Ltd.; Room 402; 6 Lianhuayan Road, Huangpu District; Guangzhou China
• For Additional Information Contact: Gavin.Liao; 86-20-3170398
• Manufacturer 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).
• FDA Determined Cause: No Marketing Application
• 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 recall@pluslife.com Mon-Fri, 9:00 AM to 6:00 PM CST Distributor by Altruan : After-Sales Team pluslife@altruan.com Mon-Fri, 9:00 AM to 5:00 PM CET
• Quantity in Commerce: 1850 boxes
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.