Device recall
Z-0538-05: Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11…
FDA device recall · Class II · Dade Behring, Inc.
Key facts
| Recall number (Z-number) | Z-0538-05 |
|---|---|
| Recall event | 30634 |
| Product | Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13. |
| Product code | DAP |
| Recalling firm | Dade Behring , Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2005 |
| 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