FDA Enforcement
Class III
Terminated
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.
Recall: Z-0745-2013
·
Reported February 6, 2013
Enforcement
- Recall Number
- Z-0745-2013
- Event ID
- 64081
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 6, 2013
- Initiation Date
- December 20, 2012
- Classification Date
- January 28, 2013
- Termination Date
- January 8, 2014
- Address
- 500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States
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
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.
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.
Distribution
Nationwide Distribution.
Quantity
5999