Device recall
Z-0881-06: Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic.
FDA device recall · Class II · Dade Behring, Inc.
Key facts
| Recall number (Z-number) | Z-0881-06 |
|---|---|
| Recall event | 35112 |
| Product | Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic. |
| Product code | JHX |
| Recalling firm | Dade Behring , Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2006 |
| 510(k) numbers | K981099 |
| FEI number | 2517506 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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