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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens Dimension(R) IRON Calibrator (DC85)

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 Class 3 Recall
Siemens Dimension(R) IRON Calibrator (DC85)
see related information
Date Posted January 29, 2013
Recall Status1 Terminated on January 08, 2014
Recall Number Z-0745-2013
Recall Event ID 64081
Premarket Notification
510(K) Number
K060266 
Product Classification Calibrator, Primary - Product Code JIS
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
For Additional Information Contact Aydee Crawford
302-631-6311
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 5999
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JIS and Original Applicant = DADE BEHRING, INC.
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