Device recall
Z-2736-2014: Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test…
FDA device recall · Class II · Nanosphere, Inc.
Key facts
| Recall number (Z-number) | Z-2736-2014 |
|---|---|
| Recall event | 68014 |
| Product | Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers. |
| 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