Device recall
Z-0172-06: Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when…
FDA device recall · Class II · Dade Behring, Inc.
Key facts
| Recall number (Z-number) | Z-0172-06 |
|---|---|
| Recall event | 32887 |
| Product | Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method. |
| Product code | DAP |
| Recalling firm | Dade Behring , Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 1, 2006 |
| 510(k) numbers | K041438 |
| FEI number | 2517506 |
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