BEUDAMED
    FDA Recall Terminated

    Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0257-2008 · Initiated October 10, 2007

    Recall

    Recall Number
    Z-0257-2008
    Event Number
    45429
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 10, 2007
    Posted
    November 24, 2007
    Terminated
    March 10, 2008
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064

    Reason

    Sample problems; Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlie

    Action

    Firm notified consignee via letter on 11/10/07. Consignee notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.

    Distribution

    Nationwide: including state of UT.

    Quantity

    1 unit.