Recall Z-0745-2013 ยท JIS Calibrator, Primary
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Jan 29, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| 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. |
| 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 | 5999 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060266 | DIMENSION IRON CALIBRATOR Dade Behring, Inc., Mar 9, 2006 |