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.
FDA Recall Z-0121-2011 · Posted 2010-10-21
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2010-07-23
Date Terminated2013-03-19
Product Quantity82
Reason for Recall
the EasyLink QCFIRST custom rule does not operate as intended.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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