BEUDAMED
    FDA Recall Open, Classified

    RX Series Copper (Cu) Assay Ref. Number CU2340

    Recall: Z-0992-2024 · Initiated November 29, 2023

    Recall

    Recall Number
    Z-0992-2024
    Event Number
    93775
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    JKZ
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    November 29, 2023
    Posted
    February 6, 2024

    Description

    RX Series Copper (Cu) Assay Ref. Number CU2340

    Reason

    Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

    Action

    RANDOX Distributors issued Medical Device Correction Letter (REC704) on December 12, 2023 to US consignees. Letter states reason for recall, health risk and action to take: Review your instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0148) " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0148) and ensure all operators are aware of the recommendations. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.

    Distribution

    US Nationwide distribution in the states of SC and OK.

    Quantity

    3,053 kits (2 US, 3,051 OUS)