BEUDAMED
    FDA Recall Terminated

    Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01. Abbott Laboratories, Santa Clara, CA 95054-1113

    Recall: Z-0455-2008 · Initiated October 27, 2006

    Recall

    Recall Number
    Z-0455-2008
    Event Number
    38465
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 27, 2006
    Posted
    March 13, 2008
    Terminated
    January 6, 2011
    Address
    5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113

    Description

    Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01. Abbott Laboratories, Santa Clara, CA 95054-1113

    Reason

    Incorrect Results: Hemoglobin results in donor samples assayed on the CELL-DYN 1800 System vary more than expected across the range of claimed operating temperatures of 18 degrees Celcius to 30 degrees Celcius.

    Action

    A Product Correction letter was sent to all customers with a reply form on October 27, 2006. Product information letters are being packed with the instrument's accessory kit and with calibrators and quality control products used with the CELL-DYN 1800 System. Correction letters with reply forms have been resent to nonresponding customers.

    Distribution

    Worldwide Distribution, USA and countries of Argentina, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Dominican Republic, El Salvador, Germany, Guatemala, Honduras, Hong Kong, China, Japan, Mexico, Paraguay, Puerto Rico, Singapore, South Korea and Venezuela.

    Quantity

    4,224 Systems