BEUDAMED
    FDA Recall Terminated

    ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.

    Recall: Z-2637-2014 · Initiated August 15, 2014

    Recall

    Recall Number
    Z-2637-2014
    Event Number
    69086
    Firm
    Data Innovations, LLC
    FEI Number
    3007289202
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 15, 2014
    Posted
    September 12, 2014
    Terminated
    March 4, 2015
    Address
    2914 Cleveland Ave, Fort Myers, FL, 33901-6003

    Description

    ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.

    Reason

    Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances.

    Action

    Data Innovations LLC sent an Important Medical Device Information letter on August 15, 2014, to consignees for the JResultNet using ProVue Instrument Driver JResultNet (provue.jrm) v. 1.5.3 and below. Potential issues with the ProVue driver have been identified which may cause data to be mis-associated with patient results under a given set of circumstances. The user on the ProVue transmits the same results twice back to back by clicking the Send to Host button twice. The ProVue sends two ASTM messages back to back before ending transmission (sending an EOT character) The solution was to disconnect JResultNet from the ProVue instrument and apply the patch to driver provue.jrm when it is available. If you have further questions regarding this notice, please feel free to contact us at [email protected] or 239-931-6004 Toll-Free (from the US and Canada): 1-800-332-0499.

    Distribution

    Nationwide Distribution including AL, AZ, CA, CT, DC, FL, GA, IN, LA, MI, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.

    Quantity

    84