Z-2644-2014Class III

JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and...

Name: Z-2644-2014 JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and...
Creator: Biofire Defense
Published: 2014-08-13
License: https://open.fda.gov/license/

BioFire Defense, LLC / initiated 2014-08-13 / Terminated / root cause: software

FDA source

Biofire Defense began a recall of JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and... on 2014-08-13. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2644-2014
Classification: Class III
Status: Terminated
Initiated: 2014-08-13
Posted: 2014-09-15
Terminated: 2016-10-24
Recalling firm: BioFire Defense, LLC
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.
Product code: NHT Assay, Nucleic Acid Amplification, Bacillus Anthracis
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.
Root cause tag: software
FDA 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 in commerce: 43 Units w/ laptops
Distribution: Distributed USA (nationwide) and Guam.
Product codes and lots: Model Number(s): JRPD-SFW-0001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2644-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2644-2014	Class III	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-15

Product code NHT

K131930Class IIJbaids Anthrax Detection KitBiofire Diagnostics, Inc. / cleared 2013-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)