BEUDAMED
    FDA Enforcement Class II Terminated

    IgE Calibrator Series

    Recall: Z-0050-2017 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-0050-2017
    Event ID
    75208
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 12, 2016
    Initiation Date
    September 7, 2016
    Classification Date
    October 6, 2016
    Termination Date
    September 7, 2017
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    IgE Calibrator Series

    Reason

    According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.

    Code Info

    Catalogue number IE2492 Batch number 354213, 386994

    Distribution

    All consignees are in the US.

    Quantity

    4