BEUDAMED
    FDA Enforcement Class III 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 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2644-2014
    Event ID
    69032
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biofire Defense
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2014
    Initiation Date
    August 13, 2014
    Classification Date
    September 15, 2014
    Termination Date
    October 24, 2016
    Address
    79 W 4500 S, N/A, Salt Lake City, UT, 84107-2649, United States

    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.

    Code Info

    Model Number(s): JRPD-SFW-0001

    Distribution

    Distributed USA (nationwide) and Guam.

    Quantity

    43 Units w/ laptops