Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON C...
FDA Recall #Z-0745-2013 — Class III — December 20, 2012
Product Description
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 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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Newark, DE
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
5999
Distribution
Nationwide Distribution.
Code Information
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
Terminated
Voluntary / Mandated
Voluntary: Firm initiated