BEUDAMED
    FDA Recall Terminated

    directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.

    Recall: Z-1786-2010 · Initiated April 15, 2010

    Recall

    Recall Number
    Z-1786-2010
    Event Number
    55404
    Firm
    International Technidyne Corporation
    FEI Number
    2250033
    Product Code
    GGN
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    April 15, 2010
    Posted
    June 11, 2010
    Terminated
    September 23, 2010
    Address
    23 Nevsky St, Edison, NJ, 08820-2425

    Description

    directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems.

    Reason

    Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.

    Action

    Notification letters were sent vis Federal Express on April 15, 2010 to all distributors and end users to return unused product or to replace the package insert. Please direct questions ITC Technical Support at phone 800-631-5945 Ext. 4707.

    Distribution

    Distributors and medical facilities in AZ, CA, IL, KY, MA, MD, ME, MO, PA, WA. Foreign distribution to Australia, Canada, Switzerland, Germany, Spain, Quatar, and Saudi Arabia.

    Quantity

    94 boxes