JBAIDS Instrument System Software version 3 — Class III medical device recall Z-2644-2014
Terminated recall by Biofire Defense, reported 2014-09-24, distributed nationwide. BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong versi
| Recall number | Z-2644-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biofire Defense, Salt Lake City, UT, United States |
| Recall initiated | 2014-08-13 |
| Classified | 2014-09-15 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2016-10-24 |
| Distributed | Nationwide (US) |
| Quantity | 43 units |
| Reason classes | software |
| Model numbers | JRPD-SFW-0001 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2644-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.