Recall Z-2644-2014 ยท NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis
Biofire Defense
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 instrument
| Date | Sep 15, 2014 (initiated Aug 13, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Consignees were notified on 8/13/14 via letter and telephone and were provider with instructions on how to install the correct software. |
| Quantity | 43 Units w/ laptops |
| Distribution | Distributed USA (nationwide) and Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131930 | JBAIDS ANTHRAX DETECTION KIT Biofire Diagnostics, Inc., Aug 5, 2013 |