BEUDAMED
    FDA Recall Terminated

    Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.

    Recall: Z-0355-04 · Initiated December 22, 2003

    Recall

    Recall Number
    Z-0355-04
    Event Number
    28041
    Firm
    Abbott Laboratories Diagnostic Div
    FEI Number
    2018433
    Product Code
    JGJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2003
    Posted
    January 16, 2004
    Terminated
    September 21, 2004
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.

    Reason

    Complaints that instructions for use were not clear.

    Action

    Firm sent customer letters dated 12/22/2003 which included updated instructions for use.

    Distribution

    Nationwide and to Mexico, Brazil, Sinagapore, Venezuela, Puerto Rico, Hong Kong, Colombia, Dominican Republic, Australia, Ecuador, Canada, New Zealand, Argentina, Germany, Bahamas, Grand Cayman, El Salvador.

    Quantity

    215