BEUDAMED
    FDA Recall Terminated

    JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis.

    Recall: Z-2644-2014 · Initiated August 13, 2014

    Recall

    Recall Number
    Z-2644-2014
    Event Number
    69032
    Firm
    Biofire Defense
    FEI Number
    3010770794
    Product Code
    NHT
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    August 13, 2014
    Posted
    September 15, 2014
    Terminated
    October 24, 2016
    Address
    79 W 4500 S, Salt Lake City, UT, 84107-2649

    Description

    JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis.

    Reason

    BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed.

    Action

    Consignees were notified on 8/13/14 via letter and telephone and were provider with instructions on how to install the correct software.

    Distribution

    Distributed USA (nationwide) and Guam.

    Quantity

    43 Units w/ laptops