BEUDAMED
    FDA Recall Terminated

    Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.

    Recall: Z-1225-2017 · Initiated November 7, 2016

    Recall

    Recall Number
    Z-1225-2017
    Event Number
    75727
    Firm
    Tosoh Bioscience, Inc.
    FEI Number
    1000123732
    Product Code
    JCM
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 7, 2016
    Terminated
    February 9, 2021
    Address
    6000 Shoreline Ct, Ste 101, South San Francisco, CA, 94080-7606

    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%.

    Action

    Recall notification letters were distributed to customers on 11/7/16. The letters instructed customers to review the chormatography to determine whether or not a variant peak was detected. If so, restest the sample using an alternative method.

    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