Device recall
Z-2154-2011: Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-2154-2011 |
|---|---|
| Recall event | 58379 |
| Product | Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Creatinine measurements are used in… |
| Product code | JFY |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 19, 2013 |
| 510(k) numbers | K090330 |
| 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