BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2362-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2362-2023
    Event ID
    92650
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 16, 2023
    Initiation Date
    June 13, 2023
    Classification Date
    August 9, 2023
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    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.

    Code Info

    Catalogue Number/GTIN (1) UR3825 05055273206906; (2) UR3873 05055273206913 ; (3) UR8334 05055273209600; (4) UR8070 05055273209594. Not Batch Specific.

    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