—#115333

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.

FDA product code: JIS — Calibrator, Primary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K060266
Affected lot / 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.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2012-12-20
Posted by FDA: 2013-01-29
Terminated: 2014-01-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115333. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.