Device recall
Z-1903-2025: VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021…
FDA device recall · Class II · Luminex Corporation
Key facts
| Recall number (Z-number) | Z-1903-2025 |
|---|---|
| Recall event | 96701 |
| Product | VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test |
| Product code | PEN |
| Recalling firm | Luminex Corporation |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K132843 |
| 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