Device product
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.
Z-2644-2014
Product summary
- Firm
- Biofire Defense
- Event
- Event 69032
- Status
- Terminated
- Classification
- Class III
- Quantity
- 43 Units w/ laptops
- Official record key
device-enforcement:Z-2644-2014
Official wording
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 information: Model Number(s): JRPD-SFW-0001
Distribution pattern: Distributed USA (nationwide) and Guam.
Derived failure modes
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Device software or design
Software version 3.5.0.72 because the wrong version software may