CLASS III Device recall · Reported 24 Sep 2014 · FDA Enforcement Report
Jbaids Instrument System recalled by Biofire Defense
Biofire Defense is recalling Jbaids Instrument System, distributed nationwide in the US. The recall was initiated on 13 Aug 2014 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2644-2014
- FDA event ID
- 69032
- Recalling firm
- Biofire Defense, Salt Lake City, UT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Aug 2014
- FDA classified
- 15 Sep 2014
- Reported
- 24 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Aug 2014 | Recall initiated by company | |
| 15 Sep 2014 | Classified by FDA | +33 days |
| 24 Sep 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Distributed USA (nationwide) and Guam.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model Number(s): JRPD-SFW-0001
Where was it sold?
Distributed USA (nationwide) and Guam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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