Device recall
Z-0772-2012: Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-0772-2012 |
|---|---|
| Recall event | 60618 |
| Product | Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System. |
| Product code | CGX |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2014 |
| 510(k) numbers | K925668 |
| 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