Z-0745-2013Class III

Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an...

Name: Z-0745-2013 Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-12-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-12-20 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used... on 2012-12-20. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0745-2013
Classification: Class III
Status: Terminated
Initiated: 2012-12-20
Posted: 2013-01-29
Terminated: 2014-01-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JIS Calibrator, Primary
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent a "CUSTOMER NOTIFICATION" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Siemens Technical Solutions Center at 1-800-441-9250 or your local Siemens Healthcare Diagnostics representative for assistance with this issue.
Quantity in commerce: 5999
Distribution: Nationwide Distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0745-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0745-2013	Class III	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-28

Product code JIS

K060266Class IIDimension Iron CalibratorDade Behring, Inc. / cleared 2006-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)