BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Immunoglobulin M, List Number 1E01-20

    Recall: Z-0384-06 · Initiated November 10, 2005

    Recall

    Recall Number
    Z-0384-06
    Event Number
    34281
    Firm
    Abbott Laboratories Diagnostic Div
    FEI Number
    2018433
    Product Code
    DFT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2005
    Posted
    January 11, 2006
    Terminated
    March 20, 2007
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Clinical Chemistry Immunoglobulin M, List Number 1E01-20

    Reason

    These specific protein assays are not meeting the 57-day on board stability claim

    Action

    A Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check..

    Distribution

    Nationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand

    Quantity

    1275 (212 in US)