BEUDAMED
    FDA Recall Terminated

    ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

    Recall: Z-0010-06 · Initiated September 14, 2005

    Recall

    Recall Number
    Z-0010-06
    Event Number
    33460
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 14, 2005
    Posted
    October 6, 2005
    Terminated
    September 25, 2007
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.

    Reason

    Software deficiency causing potential shift in absorbance readings for test results.

    Action

    Firm sent device correction letter to consignees on 9/14/2005.

    Distribution

    Nationwide and 21 foreign countries. Foreign countries: Mexico, Guatemala, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Puerto Rico, Jamaica, San Salvador, Canada, Germany, Singapore, China, Thailand, Australia, New Zealand, Panama, and Grand Cayman

    Quantity

    1,107 units