BEUDAMED
    FDA Recall Terminated

    ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.

    Recall: Z-0008-06 · Initiated February 28, 2005

    Recall

    Recall Number
    Z-0008-06
    Event Number
    33432
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 28, 2005
    Posted
    October 6, 2005
    Terminated
    November 3, 2005
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.

    Reason

    Device has incorrect notation associated with therapeutic drug monitoring assays.

    Action

    Firm sent device correction letters to consignees on 2/28/2005.

    Distribution

    California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand

    Quantity

    1,107 units worldwide