BEUDAMED
    FDA Enforcement Class II Terminated

    i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)

    Recall: Z-0926-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0926-2018
    Event ID
    79150
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Point Of Care Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 14, 2018
    Initiation Date
    September 12, 2017
    Classification Date
    March 8, 2018
    Termination Date
    August 23, 2018
    Address
    400 College Rd E, N/A, Princeton, NJ, 08540-6607, United States

    Description

    i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)

    Reason

    Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values. No erroneous results are generated as a result of this issue.

    Code Info

    All units that have been upgraded to software version 2.8

    Distribution

    Distributed in 48 States: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, Australia, Italy, Sweden, and Canada.

    Quantity

    894