BEUDAMED
    FDA Enforcement Class II Terminated

    EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.

    Recall: Z-2172-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2172-2012
    Event ID
    62448
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    June 7, 2012
    Classification Date
    August 9, 2012
    Termination Date
    August 26, 2014
    Address
    500 GBC Drive, Mailstop 514, PO BOX 6101, Newark, DE, 19714-6101, United States

    Description

    EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.

    Reason

    There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings on the following

    Code Info

    Version 5.0 and Version 5.0 Service Pack 1 through 4

    Distribution

    Worldwide distribution, including the countries of Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Switzerland and the United States, with nationwide distribution. Center Recall Depth is Retail.

    Quantity

    237