BEUDAMED
    FDA Enforcement Class III Terminated

    Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.

    Recall: Z-0601-2019 · Reported December 19, 2018

    Enforcement

    Recall Number
    Z-0601-2019
    Event ID
    81188
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2018
    Initiation Date
    October 5, 2018
    Classification Date
    December 13, 2018
    Termination Date
    June 16, 2020
    Address
    3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States

    Description

    Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.

    Reason

    Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.

    Code Info

    Lot 7055

    Distribution

    Distributed nationwide. Foreign distribution to Canada.

    Quantity

    1000