BEUDAMED
    FDA Recall Terminated

    Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20

    Recall: Z-1377-04 · Initiated July 27, 2004

    Recall

    Recall Number
    Z-1377-04
    Event Number
    29684
    Firm
    Abbott Laboratories Diagnostic Div
    FEI Number
    2018433
    Product Code
    CGX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 27, 2004
    Posted
    August 17, 2004
    Terminated
    May 2, 2012
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20

    Reason

    Precipitate formed in product.

    Action

    Firm sent recall letters requesting destruction of kits in the field on July 27, 2004.

    Distribution

    Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.

    Quantity

    758