BEUDAMED
    FDA Recall Terminated

    ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.

    Recall: Z-2221-2009 · Initiated October 27, 2008

    Recall

    Recall Number
    Z-2221-2009
    Event Number
    50488
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 27, 2008
    Posted
    September 18, 2009
    Terminated
    December 2, 2009
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038-4313

    Description

    ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.

    Reason

    When an ARCHITECT c16000 System is connected to an ACCELERATOR APS System, the software on the ACCELERATOR APS System may not generate an error warning when a Sample Presentation/Sample Queue error occurs, which could result in contamination of subsequent samples.

    Action

    Abbott Laboratories notified Customers of the affected device via a "Product Correction" letter dated October 27, 2008. Consignees provided with a temporary work around until a service representative upgrades the system software. For further information, contact your local Abbott Laboratories, Inc. service representative.

    Distribution

    International Distribution -- Spain, Italy, the United Kingdom, Sweden, Switzerland, the Netherlands, France, Canada and Scotland.

    Quantity

    15 units