Company: Biofire Defense
Date of Enforcement Report: 9/24/2014
Class lI:
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.
Recall Number Z-2644-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Biofire Defense LLC Salt Lake City, UT on 8/13/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
43 Units w/ laptops
DISTRIBUTION
Nationwide and Guam
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