FDA Medical Device Recalls (openFDA)
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 instruments and to perform PCR tests and analysis.
- Recall number
- Z-2644-2014
- Recalling firm
- Biofire Defense
- 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.
- Status
- Terminated
- Initiated
- 2014-08-13
- Posted
- 2014-09-15
- Terminated
- 2016-10-24
- 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.
- Lot, serial or model codes
- Model Number(s): JRPD-SFW-0001
- 510(k) numbers
- ["K131930"]
- PMA numbers
- not on file
- Product code
- NHT
- Firm FEI
- 3010770794
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28