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 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. |
Code Information |
Model Number(s): JRPD-SFW-0001 |
Recalling Firm/ Manufacturer |
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 3.5.0.72 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.
|