BEUDAMED
    FDA Recall Open, Classified

    Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

    Recall: Z-2362-2023 · Initiated June 13, 2023

    Recall

    Recall Number
    Z-2362-2023
    Event Number
    92650
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    CDQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 13, 2023
    Posted
    August 9, 2023

    Description

    Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

    Reason

    Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.

    Action

    RANDOX Distributors issued Medical Device Correction Letter (REC673) on June 13, 2023 to US and PR 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 organisation

    Distribution

    US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA and Puerto Rico.

    Quantity

    37 US 194 PR