BEUDAMED
    FDA Enforcement Class II Terminated

    Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880

    Recall: Z-0546-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0546-2021
    Event ID
    86827
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 16, 2020
    Initiation Date
    November 13, 2020
    Classification Date
    December 8, 2020
    Termination Date
    April 1, 2021
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880

    Reason

    Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine

    Code Info

    Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629

    Distribution

    US Nationwide distribution in the states of GA, NJ.

    Quantity

    1 kit