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U.S. Department of Health and Human Services

Class 2 Device Recall EasyLink

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 Class 2 Recall
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Date Posted October 21, 2010
Recall Status1 Terminated on March 19, 2013
Recall Number Z-0121-2011
Recall Event ID 56484
Premarket Notification
510(K) Number
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
Code Information Part # 1000034805
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
For Additional Information Contact Technical Solution Center
Manufacturer Reason
for Recall
the EasyLink QCFIRST custom rule does not operate as intended.
FDA Determined
Cause 2
Action Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated July 2010 to all customers that have the EasyLink QCFIRST custom rule installed. This Urgent Field Safety Notice included information on the problem and confirmed that a Siemens representative would contact them to facilitate the removal of the rule from the EasyLink System. For questions contact the Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.
Quantity in Commerce 82
Distribution Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, and WY and the country of Canada.
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.