Device recall
Z-0581-2009: Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and…
FDA device recall · Class II · Dade Behring, Inc.
Key facts
| Recall number (Z-number) | Z-0581-2009 |
|---|---|
| Recall event | 49608 |
| Product | Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic… |
| Product code | JJE |
| Recalling firm | Dade Behring, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2009 |
| 510(k) numbers | K073604 |
| FEI number | 2517506 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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