Device recall
Z-1978-2025: Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device…
FDA device recall · Class II · Guangzhou Pluslife Biotech Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1978-2025 |
|---|---|
| Recall event | 96896 |
| Product | 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… |
| Product code | QKP |
| Recalling firm | Guangzhou Pluslife Biotech Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3037392657 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database