BEUDAMED
    FDA Recall 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 · Initiated December 19, 2019

    Recall

    Recall Number
    Z-1349-2020
    Event Number
    84649
    Firm
    Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom
    FEI Number
    1000361607
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 19, 2019
    Posted
    February 24, 2020
    Terminated
    April 23, 2021

    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."

    Action

    Randox Medical Device Correction letter dated 12.17.2019. The recall from the manufacturer is extended to the distribution center within the USA and Puerto Rico. The distributor will then contact the customer directly. The initial contact and the follow up contact will be via email. If further contacts are required these will be via telephone. It is intended that the initial contact will be conducted 19th December 2019. The distributors and customers will be instructed to read and review the release notes and carry-out all actions specified within. Distributors are advised to contact all end-users and provide the FSN, response form and release notes. Customers were advised to take the following actions: complete and return the response form 12187-QA to technical.services@randox .com within five working days. ***Updated 3/2/2020*** The firm sent an updated customer letter on February 28, 2020, which included an updated "Risk to Health" statement, which now states that a delay in reporting results could lead to a delay in diagnosis and/or treatment. No erroneous patient results are generated due to this issue. Instructions to customers have not changed.

    Distribution

    US Nationwide distribution including state of PR.

    Quantity

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