Device recall
Z-2170-2014: Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using…
FDA device recall · Class II · Nanosphere, Inc.
Key facts
| Recall number (Z-number) | Z-2170-2014 |
|---|---|
| Recall event | 68177 |
| Product | Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed… |
| Product code | PEN |
| Recalling firm | Nanosphere, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 14, 2016 |
| 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