FDA Device recall Z-2644-2014
JBAIDS Instrument System Software version 3.5.0.72
- FDA Device
- Class III
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class III recall of JBAIDS Instrument System Software version 3.5.0.72 by Biofire Defense, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2644-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-08-13 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biofire Defense |
| Distribution | US |
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.
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.
Identifiers
| code_info | Model Number(s): JRPD-SFW-0001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2644-2014%22
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