The Recall Desk
LowFDA (Devices)·Z-2644-2014·Announced 2014-09-24

BioFire Defense Recalls JBAIDS Instrument System Software Version 3.5.0.72

BioFire Defense is recalling JBAIDS Instrument System Software version 3.5.0.72 because the wrong version may have been installed on the devices.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software version mismatch without reported injuries or illnesses.

Plain-English summary

BioFire Defense, LLC is initiating a field action for JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter used for the simultaneous and rapid identification of multiple biological warfare and clinical pathogens. The software provides an integrated environment for controlling the instruments and performing PCR tests and analysis.

The recall is being conducted because the wrong version of the software may have been installed on the units. This field action involves 43 units with laptops, which were distributed nationwide in the United States and in Guam. The model number for the affected software is JRPD-SFW-0001.

Users of the JBAIDS Instrument System Software version 3.5.0.72 should contact BioFire Defense for further instructions regarding the field action.

The recalled product

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 sof
Manufacturer
Biofire Defense
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
43

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model Number(s): JRPD-SFW-0001

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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