Recall Z-1978-2025 ยท QKP Coronavirus Antigen Detection Test System.
Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction m
| 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 | 541 units |
| 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.