PlainRecalls
FDA Devices Low Class III 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.

Reported: September 24, 2014 Initiated: August 13, 2014 #Z-2644-2014

Product Description

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.

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.

Details

Recalling Firm
Biofire Defense
Units Affected
43 Units w/ laptops
Distribution
Distributed USA (nationwide) and Guam.
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Biofire Defense. Units affected: 43 Units w/ laptops.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 24, 2014. Severity: Low. Recall number: Z-2644-2014.

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