BEUDAMED
    FDA Enforcement Class II Terminated

    Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

    Recall: Z-1225-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1225-2017
    Event ID
    75727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2017
    Initiation Date
    November 7, 2016
    Classification Date
    February 17, 2017
    Termination Date
    February 9, 2021
    Address
    6000 Shoreline Ct Ste 101, N/A, South San Francisco, CA, 94080-7606, United States

    Description

    Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

    Reason

    The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.

    Code Info

    All active analyzers

    Distribution

    Worldwide distribution. The products were shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, AND WY. The recalled products were shipped to the following countries: Brazil, Chile, Columbia, Guatemala, Costa Rica, Dominican Republic, Eduador, Nicaragua, Panama, Peru, Puerto Rico, Uruguay,

    Quantity

    682 analyzers