JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluor
FDA device recall Z-2644-2014 · posted 2014-09-15 · Terminated
Recall details
- Recalling firm
- Biofire Defense
- 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.
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- NHT
- Quantity affected
- 43 Units w/ laptops
- Distribution
- Distributed USA (nationwide) and Guam.
- Date initiated
- 2014-08-13
- Date posted
- 2014-09-15
- Date terminated
- 2016-10-24
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JBAIDS ANTHRAX DETECTION KIT (K131930) | Biofire Diagnostics, Inc. | 2013-08-05 |