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Terminated

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.

FDA Recall Z-2644-2014 · Posted 2014-09-15

Recalling FirmBiofire Defense
Recall StatusTerminated
Product CodeNHT
Date Initiated2014-08-13
Date Terminated2016-10-24
Product Quantity43 Units w/ laptops

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.

Firm Action

Consignees were notified on 8/13/14 via letter and telephone and were provider with instructions on how to install the correct software.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

Distributed USA (nationwide) and Guam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131930JBAIDS ANTHRAX DETECTION KITBiofire Diagnostics, Inc. · 2013-08-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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