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U.S. Department of Health and Human Services

Class 2 Device Recall EasyLink(TM) Informatics Systems

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  Class 2 Device Recall EasyLink(TM) Informatics Systems see related information
Date Initiated by Firm December 02, 2011
Date Posted April 10, 2012
Recall Status1 Terminated 3 on March 21, 2014
Recall Number Z-1391-2012
Recall Event ID 61347
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System.

The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
Product Quantity Distributed (Int) 787
Code Information Catalog number 1000034805
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Robert J. King
302-631-0516
Manufacturer Reason
for Recall		 QC results may be unexpectedly associated with a Pending Control. When this situation occurs, Pending QC Controls maybe be created or reused.
FDA Determined
Cause 2		 Device Design
Action Siemens Healthcare Diagnostic Inc, sent a Urgent Field Safety Notice dated December 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were asked to follow these instructions. The first option is Extending the "Minimum Inactive Days" to 999 days. The second option is to proactively monitor the system for unexpected Pending QC Controls. Long Term Action Plan: A corrective and preventive action (CAPA) investigation has been issued. Currently firm is actively investigating. Further questions please call (302) 631-0516.
Quantity in Commerce 787
Distribution Worldwide Distribution -- USA (nationwide) and the countries of CANADA, FRANCE, GERMANY, SPAIN, PORTUGAL, ITALY, JAPAN, NORWAY, AUSTRALIA, AUSTRIA, NEW ZEALAND, BELGIUM, SWITZERLAND, NETHERLANDS, MALAYASIA, SLOVENIA, SOUTH KOREA, DENMARK, SAUDI ARABIA, SLOVAKIA, PUERTO RICO, INDONESIA and TAIWAN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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