Z-2644-2014 Class III Terminated
FDA device recall Z-2644-2014 was initiated by Biofire Defense on August 13, 2014 and is designated Class III. 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. The recall status is terminated (terminated October 24, 2016). Affected quantity: 43 Units w/ laptops.
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2014
- Initiation Date
- August 13, 2014
- Termination Date
- October 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 Units w/ laptops
Product 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 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 Pattern
Distributed USA (nationwide) and Guam.
Code Information
Model Number(s): JRPD-SFW-0001