BEUDAMED
    FDA Enforcement Class II Terminated

    AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.

    Recall: Z-0864-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0864-2020
    Event ID
    84496
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer Medical ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2020
    Initiation Date
    August 8, 2019
    Classification Date
    January 24, 2020
    Termination Date
    June 6, 2022
    Address
    Akandevej 21, N/A, Bronshoj, N/A, N/A, Denmark

    Description

    AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.

    Reason

    The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.

    Code Info

    Software version 2.3.5 and below

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; and countries of:  Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Italy, Japan (Tokyo-not a country but it was listed), Netherlands, Norway, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.

    Quantity

    947