Severity
Low
Biofire Defense issued this FDA Devices recall on September 24, 2014. Classified as Low severity (Class III). Approximately 43 Units w/ laptops units are affected. The recall was issued because: BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version softwa…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
This FDA Devices action (record #Z-2644-2014) was formally reported on September 24, 2014, with the manufacturer initiating the action on August 13, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Biofire Defense is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records indicate 43 Units w/ laptops units are affected.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Distributed USA (nationwide) and Guam.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Severity
Low
Units Affected
43 Units w/ laptops
Related Recalls
6
6 from same agency
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.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2644-2014 |
| Date reported | September 24, 2014 |
| Date initiated | August 13, 2014 |
| Recalling firm | Biofire Defense |
| Units affected | 43 Units w/ laptops |
| Distribution | Distributed USA (nationwide) and Guam. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
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Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).