FDA Device recall Z-0745-2013
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010
- FDA Device
- Class III
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class III recall of Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010 by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0745-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-12-20 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
Reason
Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.
Identifiers
| code_info | Siemens material number 10445010 -- and lot numbers 2DN060, exp 2013-10-01; 2FN063, exp 2013-12-01; 2GN068, exp 2014-01-01; and 2JN073, exp 2014-03-01. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0745-2013%22
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