BEUDAMED
    FDA Enforcement Class III Terminated

    G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.

    Recall: Z-1075-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1075-2013
    Event ID
    56584
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 17, 2013
    Initiation Date
    August 18, 2010
    Classification Date
    April 9, 2013
    Termination Date
    May 13, 2014
    Address
    3600 Gantz Road, Grove City, OH, 43123, United States

    Description

    G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.

    Reason

    The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received complaints that the A2 peak could not be detected with the G7 Beta-thalessemia columns.

    Code Info

    11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.

    Distribution

    Worldwide Distribution-USA (nationwide) including DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.

    Quantity

    633