Recall Z-1979-2025
Guangzhou Pluslife Biotech Co., Ltd. · initiated January 24, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Model/Catalog Number: RM1010202; Lot numbers: All lots of the COVID-19 test kits in the U.S.
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 taken
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
Details
- Recall number
- Z-1979-2025
- Initiated
- January 24, 2025
- Posted by FDA
- June 13, 2025
- Product code
- QKP – Coronavirus Antigen Detection Test System.
- Quantity
- 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…
- Recalling firm
- Guangzhou Pluslife Biotech Co., Ltd., Guangzhou
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1978-2025 Class II | Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog…Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization… | 01/24/2025Open, Classified |