Recall Z-0745-2013— Siemens Healthcare Diagnostics, Inc.
Class III · Terminated
Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-12-20, terminated 2014-01-08. It names one FDA 510(k) clearance: K060266. 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-12-20
- Terminated
- 2014-01-08
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.