FDA Device recall Z-0517-2014
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacro…
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacro… by Siemens Healthcare Diagnostics, citing siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0517-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-25 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients
Reason
Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.
Identifiers
| code_info | Siemens Material Number 10444938, lot numbers GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267 and FB3267. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0517-2014%22
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