BEUDAMED
    FDA Recall Terminated

    Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.

    Recall: Z-0837-2013 · Initiated September 28, 2012

    Recall

    Recall Number
    Z-0837-2013
    Event Number
    64076
    Firm
    International Technidyne Corp.
    FEI Number
    1000526865
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    September 28, 2012
    Posted
    February 19, 2013
    Terminated
    January 9, 2014
    Address
    68 Olsen Ave, Edison, NJ, 08820-2419

    Description

    Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.

    Reason

    Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.

    Action

    ITC sent an 'Urgent Medical Device Recall' letter/Health Professional Account Tracking Form dated October 2, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the form whether or not they have remaining inventory of these lots and return the form promptly. All unused returned product will be replaced. Any questions can be directed to ITC Technical Support at 800-631-5945 Extension 4707 or e-mail [email protected]. For questions regarding this recall call 800-631-5945, ext. 4707.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany, Italy, Latvia, Lithuania, Malaysia, Philippines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates.

    Quantity

    11,742 boxes US (25 cuvettes per box); 22,968 boxes OUS (25 cuvettes per box)