Device recall
Z-1044-2012: STA - System Control N + P Product Usage: The STA -System Control N+P kit…
FDA device recall · Class II · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-1044-2012 |
|---|---|
| Recall event | 61019 |
| Product | STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAbrand name suitable to these reagents: -the Reagent 1 (STA-System Control N)is… |
| Product code | GGN |
| Recalling firm | Diagnostica Stago, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2013 |
| 510(k) numbers | K943518 |
| FEI number | 2245451 |
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