BEUDAMED
    FDA Enforcement Class II Terminated

    The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.

    Recall: Z-0949-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0949-2014
    Event ID
    65214
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sysmex America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2014
    Initiation Date
    March 31, 2013
    Classification Date
    February 10, 2014
    Termination Date
    August 15, 2016
    Address
    1 Nelson C White Pkwy, N/A, Mundelein, IL, 60060-9528, United States

    Description

    The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.

    Reason

    The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. This resulted in the database files meeting its maximum capacity and causing system p

    Code Info

    Software versions 1.0, 1.01, 1.1.1, 1.1.2

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IS, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and WI and the country of Canada.

    Quantity

    214 units