BEUDAMED
    FDA Enforcement Class II Terminated

    Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.

    Recall: Z-1809-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1809-2018
    Event ID
    79708
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    March 5, 2018
    Classification Date
    May 14, 2018
    Termination Date
    June 16, 2020
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895, United States

    Description

    Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.

    Reason

    The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

    Code Info

    All lots.

    Distribution

    USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

    Quantity

    6049