BEUDAMED
    FDA Enforcement Class II Terminated

    Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

    Recall: Z-2013-2021 · Reported July 14, 2021

    Enforcement

    Recall Number
    Z-2013-2021
    Event ID
    88098
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 14, 2021
    Initiation Date
    April 28, 2021
    Classification Date
    July 6, 2021
    Termination Date
    December 3, 2021
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

    Reason

    An issue was identified where the software froze during processing of commands, which resulted in no results displayed.

    Code Info

    GTIN 05055273206104, Serial Numbers: 7201-0423 7201-0417 7201-0353 7201-0776 7201-0367 7201-0921 7201-0982 7201-0977 7201-0970 7201-0950 7201-0924 7201-0919 7201-0901 7201-0849 7201-0827 7201-0799 7201-0801 7201-0768 7201-0606 7201-0562 7201-0535 7201-0531 7201-0381 7201-0112 7201-0231 7201-0275 7201-0299 7201-0319 7201-0343 7201-0348 7201-0391 7201-0514 7201-0515 7201-0540 7201-0605 7201-0616 7201-0840 7201-0533 7201-0932 7201-0943 7201-0513 7201-0482 7201-0960 7201-0882 7201-0434 7201-0607 7201-0768 7201-0961 7201-0980 7201-0994

    Distribution

    US Nationwide Distribution and Puerto Rico.

    Quantity

    50 kits