Device recall
Z-0445-2019: VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack…
FDA device recall · Class II · Luminex Corporation
Key facts
| Recall number (Z-number) | Z-0445-2019 |
|---|---|
| Recall event | 81220 |
| Product | VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria. |
| Product code | PAM |
| Recalling firm | Luminex Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 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