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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens Dimension(R) EXL(TM) 200

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 Class 3 Recall
Siemens Dimension(R) EXL(TM) 200
see related information
Date Posted April 01, 2013
Recall Status1 Terminated on January 14, 2014
Recall Number Z-1048-2013
Recall Event ID 64570
Premarket Notification
510(K) Number
K073604 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
Code Information Siemens Material Number 10636929
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark, Delaware 19702-2466
For Additional Information Contact Customer Support
302-631-6311
Manufacturer Reason
for Recall
Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Siemens initiated their recall of this product on February 27, 2013 by sending an Important Customer Notification letter to consignees by FedEx. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce 2207 total
Distribution Worldwide 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 = JJE and Original Applicant = DADE BEHRING, INC.
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