BEUDAMED
    FDA Recall Terminated

    AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30

    Recall: Z-0240-04 · Initiated November 24, 2003

    Recall

    Recall Number
    Z-0240-04
    Event Number
    27822
    Firm
    Abbott Laboratories Diagnostic Div
    FEI Number
    2018433
    Product Code
    CDQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 24, 2003
    Posted
    December 18, 2003
    Terminated
    January 25, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30

    Reason

    False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.

    Action

    Firm sent letter to customers dated November 24,2003 which includes a new package insert to use with this reagent. Instructions were changed to correct low resulting situation. Subrecall was requested.

    Distribution

    Nationwide and Mexico, Brazil, Germany, Singapore, Grand Cayman, Venezuela, Puerto Rico, Hong Kong, Australia, Columbia, Dominican Republic, China, Trinidad, Argentina, Canada, New Zealand, Bahamas

    Quantity

    All lots.