BEUDAMED
    FDA Recall Terminated

    Synchron LX Systems Version 4.5 Operating Software

    Recall: Z-0009-06 · Initiated September 6, 2005

    Recall

    Recall Number
    Z-0009-06
    Event Number
    33453
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 6, 2005
    Posted
    October 6, 2005
    Terminated
    January 26, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Synchron LX Systems Version 4.5 Operating Software

    Reason

    Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.

    Action

    Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.

    Distribution

    Nationwide and Canada

    Quantity

    868