BEUDAMED
    FDA Recall Terminated

    UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4

    Recall: Z-1440-06 · Initiated May 15, 2006

    Recall

    Recall Number
    Z-1440-06
    Event Number
    35646
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    NDW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 15, 2006
    Posted
    August 26, 2006
    Terminated
    April 8, 2013
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4

    Reason

    Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results.

    Action

    A Product Correction Action (PCA) letter was sent the week of May 15, 2006 to all Unicel DxC customers informing them not to leave any Lithium reagent cartridge onboard a UniCel DxC System past 14 days. They also were instructed to complete and return the enclosed response form. The Letter was sent by US Mail.

    Distribution

    Nationwide and Canada

    Quantity

    524