BEUDAMED
    FDA Enforcement Class III Terminated

    Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

    Recall: Z-1106-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1106-2019
    Event ID
    82184
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2019
    Initiation Date
    February 7, 2019
    Classification Date
    April 8, 2019
    Termination Date
    June 8, 2020
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

    Reason

    The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

    Code Info

    Lot codes: 1714EC 430312 432364

    Distribution

    The products were distributed to the following US states: WV and Puerto Rico.

    Quantity

    12