BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1075-2013 · Initiated August 18, 2010

    Recall

    Recall Number
    Z-1075-2013
    Event Number
    56584
    Firm
    Tosoh Bioscience Inc
    FEI Number
    3005529799
    Product Code
    JPD
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    August 18, 2010
    Posted
    April 10, 2013
    Terminated
    May 13, 2014
    Address
    3600 Gantz Road Grove, City, OH, 43123

    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.

    Action

    Please be aware that this is not a new recall. The firm has taken action. The firm stated that they have notified consignees via mail, with the list of notified customers maintained by the Regulatory Affairs/Quality Assurance department. The firm stated that they have notified distributors in the same way that they have notified other consignees, with a required confirmation to the firm of corrective actions.

    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