Device recall
Z-1924-2013: Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1924-2013 |
|---|---|
| Recall event | 65706 |
| Product | Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an… |
| Product code | MLM |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 26, 2014 |
| 510(k) numbers | K060502 |
| 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