BEUDAMED
    FDA Enforcement Class III Terminated

    G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.

    Recall: Z-2066-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2066-2015
    Event ID
    71493
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    February 10, 2015
    Classification Date
    July 14, 2015
    Termination Date
    October 1, 2015
    Address
    6000 Shoreline Ct Ste 101, N/A, South San Francisco, CA, 94080-7606, United States

    Description

    G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.

    Reason

    The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.

    Code Info

    Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015

    Distribution

    Us Nationwide Distribution in the state ID including PR.

    Quantity

    9 boxes/5 pouches