Device recall
Z-2775-2020: Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture…
FDA device recall · Class II · Luminex Corporation
Key facts
| Recall number (Z-number) | Z-2775-2020 |
|---|---|
| Recall event | 85872 |
| Product | Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested. |
| Product code | PAM |
| Recalling firm | Luminex Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2023 |
| 510(k) numbers | K122514 |
| FEI number | 3002524000 |
At a glance
- 1–9 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