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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69032

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 13, 2014
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Biofire Defense

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2644-2014
Recall number
Z-2644-2014
Initiated
August 13, 2014
Classification
Class III
Status
Terminated
Recalling firm
Biofire Defense
Quantity
43 Units w/ laptops

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software version 3.5.0.72 because the wrong version software may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Number(s): JRPD-SFW-0001

Distribution pattern

Distributed USA (nationwide) and Guam.