| Date Posted |
January 29, 2013 |
| Recall Number |
Z-0745-2013 |
| 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. |
| 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.
|
Recalling Firm/
Manufacturer |
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark, Delaware 19702-2466 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Aydee Crawford
302-631-6311
|
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.
|
| 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. |
| |
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