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.
This recall has been terminated (originally issued September 15, 2014).
- Company
- Biofire Defense
- Recall Initiated
- August 13, 2014
- Posted
- September 15, 2014
- Terminated
- October 24, 2016
- Recall Number
- Z-2644-2014
- Quantity
- 43 Units w/ laptops
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distributed USA (nationwide) and Guam.
Lot / Code Info
Model Number(s): JRPD-SFW-0001
Root Cause
Software Manufacturing/Software Deployment
Action Taken
Consignees were notified on 8/13/14 via letter and telephone and were provider with instructions on how to install the correct software.