Device recall
Z-1043-2012: Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1043-2012 |
|---|---|
| Recall event | 60982 |
| Product | Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitivity to lupus-like inhibitors for use in the determination of the activated partial thromboplastin time… |
| Product code | GGW |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2014 |
| 510(k) numbers | K863594 |
| FEI number | 2517506 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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