BEUDAMED
    FDA Enforcement Class II Terminated

    G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

    Recall: Z-1254-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1254-2019
    Event ID
    82550
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 8, 2019
    Initiation Date
    April 3, 2019
    Classification Date
    May 2, 2019
    Termination Date
    October 9, 2019
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

    Reason

    The target values and ranges in these lots are incorrect.

    Code Info

    Lot Numbers: 687PD 700PD 715PD

    Distribution

    The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.

    Quantity

    14 kits