BEUDAMED
    FDA Enforcement Class II Terminated

    AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

    Recall: Z-0748-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0748-2016
    Event ID
    72959
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2016
    Initiation Date
    December 29, 2015
    Classification Date
    February 3, 2016
    Termination Date
    March 29, 2016
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

    Reason

    The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.

    Code Info

    Model Number: 933-599 Version 1.8.3

    Distribution

    Worldwide Distribution-US (nationwide) including the states of PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.

    Quantity

    375