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U.S. Department of Health and Human Services

Class 3 Device Recall JBAIDS Instrument System Software version

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  Class 3 Device Recall JBAIDS Instrument System Software version see related information
Date Initiated by Firm August 13, 2014
Date Posted September 15, 2014
Recall Status1 Terminated 3 on October 24, 2016
Recall Number Z-2644-2014
Recall Event ID 69032
510(K)Number K131930  
Product Classification Assay, nucleic acid amplification, bacillus anthracis - Product Code NHT
Product JBAIDS Instrument System Software version

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.
Code Information Model Number(s): JRPD-SFW-0001
Recalling Firm/
Biofire Defense
79 W 4500 S
Salt Lake City UT 84107-2649
For Additional Information Contact Amber Bawden
801-262-3592 Ext. 1458
Manufacturer Reason
for Recall
BioFire Defense, LLC is initiating a field action for JBAIDS Software version because the wrong version software may have been installed.
FDA Determined
Cause 2
Software Manufacturing/Software Deployment
Action Consignees were notified on 8/13/14 via letter and telephone and were provider with instructions on how to install the correct software.
Quantity in Commerce 43 Units w/ laptops
Distribution Distributed USA (nationwide) and Guam.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NHT and Original Applicant = BIOFIRE DIAGNOSTICS, INC.