Device recall
Z-2952-2018: Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and…
FDA device recall · Class II · Luminex Corporation
Key facts
| Recall number (Z-number) | Z-2952-2018 |
|---|---|
| Recall event | 80517 |
| Product | Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. |
| Product code | PCH |
| Recalling firm | Luminex Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 29, 2020 |
| 510(k) numbers | K142033 |
| 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