Device recall
Z-1979-2025: Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid…
FDA device recall · Class II · Guangzhou Pluslife Biotech Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1979-2025 |
|---|---|
| Recall event | 96896 |
| 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… |
| 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