BEUDAMED
    FDA Recall Terminated

    Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL

    Recall: Z-0551-2008 · Initiated October 25, 2007

    Recall

    Recall Number
    Z-0551-2008
    Event Number
    45873
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 25, 2007
    Posted
    January 25, 2008
    Terminated
    April 1, 2008
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL

    Reason

    Sample/Patient Mis-identification: Two issues identified related to the ACCELERATOR Decision Manager (ADM), to include: 1) Sample Identification (SID) and/or Patient Identification (PID) numbers that contain more than 12 characters are truncated to the final 12 characters by the ADM; 2) for SIDs using alpha characters that are case sensitive, SIDs with lower case characters are transmitted by the

    Action

    Firm notified consignees via Product Correction, Immediate Action Required letter(s) on 10/25/07. Consignees were notified of software issues and informed they would be contacted by an Abbott representative to schedule installation of software upgrade.

    Distribution

    Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV.

    Quantity

    19 units.