Device recall
Z-0485-2009: Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is…
FDA device recall · Class II · Dade Behring, Inc.
Key facts
| Recall number (Z-number) | Z-0485-2009 |
|---|---|
| Recall event | 50075 |
| Product | Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal… |
| Product code | JFY |
| Recalling firm | Dade Behring, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 27, 2009 |
| 510(k) numbers | K073055 |
| 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