CLASS III Device recall · Reported 6 Feb 2013 · FDA Enforcement Report
Dimension(R) IRON Calibrator (DC85) recalled
Siemens Healthcare Diagnostics is recalling Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010, distributed nationwide in the US. The recall was initiated on 20 Dec 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0745-2013
- FDA event ID
- 64081
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Dec 2012
- FDA classified
- 28 Jan 2013
- Reported
- 6 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Dec 2012 | Recall initiated by company | |
| 28 Jan 2013 | Classified by FDA | +39 days |
| 6 Feb 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010 recalled?
Yes. Siemens Healthcare Diagnostics recalled Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010 on 20 Dec 2012. The recall is Class III and its status is Terminated. Recall number Z-0745-2013.
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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