Recall Z-1979-2025 ยท QKP Coronavirus Antigen Detection Test System.
Guangzhou Pluslife Biotech Co., Ltd.
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), Disposabl
| Date | Jun 13, 2025 (initiated Jan 24, 2025) |
| Status | Open, Classified |
| Reason | Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA). |
| Root 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 |
| 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, M |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.