BEUDAMED
    FDA Enforcement Class II Terminated

    RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

    Recall: Z-2059-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2059-2018
    Event ID
    79968
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 13, 2018
    Initiation Date
    May 4, 2018
    Classification Date
    June 4, 2018
    Termination Date
    June 16, 2020
    Address
    515 Industrial Blvd, N/A, Kearneysville, WV, 25430-2778, United States

    Description

    RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.

    Reason

    Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.

    Code Info

    GTIN 05055273206104. All serial numbers.

    Distribution

    US Distribution including Puerto Rico and the state of : West Virginia.

    Quantity

    41 analyzers