Device recall
Z-1233-2010: Envoy 500 Serum Control Kit. The device is used for monitoring the performance…
FDA device recall · Class II · Vital Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1233-2010 |
|---|---|
| Recall event | 54279 |
| Product | Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range. |
| Product code | JJY |
| Recalling firm | Vital Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2012 |
| 510(k) numbers | K040273 |
| FEI number | 1717966 |
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