FDAFDA · Food and drugs·Recall number Z-2644-2014
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.
Published September 24, 2014 · Recall initiated: August 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biofire Defense
- Distributor
- Distributed USA (nationwide) and Guam.
- Lot
- Model Number(s): JRPD-SFW-0001
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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