Device recall
Z-0054-2021: VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device…
FDA device recall · Class II · Luminex Corporation
Key facts
| Recall number (Z-number) | Z-0054-2021 |
|---|---|
| Recall event | 86358 |
| Product | VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids |
| Product code | OCC |
| Recalling firm | Luminex Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K143653 |
| 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