FDA-Device2014-09-24Class III
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.
Biofire Defense
Hazard
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.
Sold states
Distributed USA (nationwide) and Guam.
Affected count
43 Units w/ laptops
Manufactured in
79 W 4500 S, N/A, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2644-2014Don't want to check this manually?
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