BEUDAMED
    FDA Recall Terminated

    VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.

    Recall: Z-2323-2012 · Initiated July 23, 2012

    Recall

    Recall Number
    Z-2323-2012
    Event Number
    62757
    Firm
    Trek Diagnostic Systems
    FEI Number
    1000515493
    Product Code
    MDB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 23, 2012
    Posted
    September 6, 2012
    Terminated
    June 18, 2013
    Address
    982 Keynote Cir, Ste 6, Cleveland, OH, 44131-1873

    Description

    VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.

    Reason

    Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the VersaTREK instrument, the positive test result inadvertently reverted to a negative result in the instrument database.

    Action

    ThermoFisher Scientific sent an Important Medical Device Product Correction Notice dated July 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact the Technical Service Department at 800-642-7029 to schedule their upgrade and to complete and return the Correction Notice Customer Acknowledgement by fax or in the enclosed return envelope. Customers were also asked to return the checklist. For questions customers were instructed to call 800-642-7029. For questions regarding this recall call 913-985-4185.

    Distribution

    Worldwide Distribution - USA including AL, AR, AZ, CA, CO , CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV, and WY. Internationally to the countries of Bahamas, Bangladesh, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, India, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Pakistan, Peru, Philippines, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Thailand, Turkey, and United Kingdom

    Quantity

    333 units