Device recall
Z-0476-2021: Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with…
FDA device recall · Class II · Luminex Corporation
Key facts
| Recall number (Z-number) | Z-0476-2021 |
|---|---|
| Recall event | 86124 |
| Product | Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for… |
| Product code | PAM |
| Recalling firm | Luminex Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2024 |
| 510(k) numbers | K143653 |
| FEI number | 3006028115 |
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