BEUDAMED
    FDA Recall 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 · Initiated February 10, 2015

    Recall

    Recall Number
    Z-2066-2015
    Event Number
    71493
    Firm
    Tosoh Bioscience, Inc.
    FEI Number
    1000123732
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 10, 2015
    Posted
    July 14, 2015
    Terminated
    October 1, 2015
    Address
    6000 Shoreline Ct, Ste 101, South San Francisco, CA, 94080-7606

    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.

    Action

    Tosoh Bioscience sent an Urgent Recall Notification letters dated February 10, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard any remaining pouches of the product, complete and return the attached response form. For questions call Tosoh Technical Support at 1-800-248-6764.

    Distribution

    Us Nationwide Distribution in the state ID including PR.

    Quantity

    9 boxes/5 pouches