Guangzhou Pluslife Biotech Co., Ltd. recalls Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Car…

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

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

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

• FDA enforcement recordOfficial FDA database entry for Z-1979-2025
• FDA device classification · QKPOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Guangzhou Pluslife Biotech Co., Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.