BEUDAMED
    FDA Enforcement Class II Terminated

    RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.

    Recall: Z-1349-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1349-2020
    Event ID
    84649
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories, Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 4, 2020
    Initiation Date
    December 19, 2019
    Classification Date
    February 24, 2020
    Termination Date
    April 23, 2021
    Address
    Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, N/A, United Kingdom

    Description

    RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.

    Reason

    Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample identification number) when searching the run/results screen; 2) Incorrect color flagging of IQC as "out of range."

    Code Info

    Software version UI2550642107 for the RX Daytona Plus instrument.

    Distribution

    US Nationwide distribution including state of PR.

    Quantity

    U.S.: RX4040-2 units RX 4041-3 units