BEUDAMED
    FDA Recall Terminated

    Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments

    Recall: Z-2173-2012 · Initiated June 7, 2012

    Recall

    Recall Number
    Z-2173-2012
    Event Number
    62403
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    June 7, 2012
    Posted
    August 9, 2012
    Terminated
    April 1, 2014
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments

    Reason

    The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sys

    Action

    Siemens Healtcare Diagnostics sent a Urgent Field Safety Notice dated June 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to discuss the contents of this letter with your Laboratory Director regarding the need to review any previous test results. If you have any technical questions or concerns, please contact the Seimens Technical Solutions Center at 1-800-441-9250, for further assistance.

    Distribution

    USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.

    Quantity

    15