BEUDAMED
    FDA Recall Terminated

    The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas

    Recall: Z-0263-04 · Initiated November 17, 2003

    Recall

    Recall Number
    Z-0263-04
    Event Number
    27731
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2003
    Posted
    December 24, 2003
    Terminated
    October 28, 2004
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75015-2020

    Description

    The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas

    Reason

    Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234)

    Action

    The firm plans to distribute a Product Information Letter and an updated ARCHITECT i System Operations Manufal Addendum to all US ARCHITECT customers. An electronic version of these documents was sent to all Abbott affilities worldwide for distribution to their ARCHITECT customers.

    Distribution

    Mexico, Puerto Rico, Japan, Taiwan, Australia, Colombia, Cananda, Hong Kong, New Zealand, Netherlands, Singapore, Germany, Grand Cayman, Korea, Chile, Thailand, TX, PA, SC, CA, IN.

    Quantity

    148