BEUDAMED
    FDA Enforcement Class II Terminated

    Magnesium on RX Imola analyser IVD

    Recall: Z-0725-2017 · Reported December 14, 2016

    Enforcement

    Recall Number
    Z-0725-2017
    Event ID
    75263
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories, Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 14, 2016
    Initiation Date
    April 14, 2016
    Classification Date
    December 8, 2016
    Termination Date
    September 19, 2017
    Address
    Ardmore 55 The Diamond Road, N/A, Crumlin, N/A, N/A, United Kingdom

    Description

    Magnesium on RX Imola analyser IVD

    Reason

    According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid wash recommended when setting up the magnesium assay. A correction was made to the IFU for the Magnesium assay and all RX Imola customers in the USA were contacted with the updated instruction.

    Code Info

    reagent: MG3880 analyser: RX4900

    Distribution

    Nationwide Distribution The product was only distributed to US Consignees.

    Quantity

    15