BEUDAMED
    FDA Recall 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 · Initiated June 7, 2012

    Recall

    Recall Number
    Z-2172-2012
    Event Number
    62448
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 7, 2012
    Posted
    August 9, 2012
    Terminated
    August 26, 2014
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    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

    Action

    The firm initiated this recall on June 7, 2012 by issuing an "Urgent Field Safety Notice" to all customers who are known to have the EasyLink system and who also own and operate Sysmex CA-1500 and CA-7000 instruments. The Notice described the problem and provided recommended actions. Customers can contact 800-441-9250 for questions.

    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