BEUDAMED
    FDA Recall Terminated

    International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol.

    Recall: Z-0470-2007 · Initiated December 6, 2006

    Recall

    Recall Number
    Z-0470-2007
    Event Number
    36956
    Firm
    International Technidyne Corp.
    FEI Number
    1000526865
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 6, 2006
    Posted
    January 13, 2007
    Terminated
    April 26, 2007
    Address
    6-8 Olsen Ave, Edison, NJ, 08820-2419

    Description

    International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol.

    Reason

    Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature.

    Action

    Medical Device Correction letters were sent on 12/6/2006 by first class mail along with a replacement Operator's manual. On 3/19/07 the firm sent and additional letter to customers in order to ensure that self testers, as well as health care professionals and distributors were notified.

    Distribution

    Nationwide to health care professionals and ITC distributors

    Quantity

    1,541 units