BEUDAMED
    FDA Recall Terminated

    IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.

    Recall: Z-2954-2011 · Initiated May 10, 2011

    Recall

    Recall Number
    Z-2954-2011
    Event Number
    58043
    Firm
    International Technidyne Corp.
    FEI Number
    1000526865
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 10, 2011
    Posted
    August 5, 2011
    Terminated
    November 2, 2012
    Address
    68 Olsen Ave, Edison, NJ, 08820-2419

    Description

    IL GEM PCL/PCL Plus - Gem Test PT Cartridge ITC-Nexus Dx A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.

    Reason

    Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference. instruments.

    Action

    International Technidyne Corp. (ITC) sent "Urgent Medical Device Recall" letters dated May 10, May 25 and June 09, 2011 to all affected customers. The letter included a description of the problem, asked customers fill out the attached form, and return affected product for replacement. For questions, please contact ITC Technical Support at (800) 631-5945.

    Distribution

    Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.

    Quantity

    265 boxes total