BioFire Diagnostics, LLC is recalling 5,406 FilmArray TORCH systems, specifically the BIOFIRE TORCH Base units, due to a defect in the power entry switch. The internal components of the switch can experience electrical arcing, which causes carbon to build up on the contacts and leads to extreme heating. This heat can deform the plastic switch case, potentially causing the device to lose power or experience a short circuit during use. These automated diagnostic devices were distributed worldwide between October 2023 and the present.
Excessive heat build-up inside the power switch can cause the casing to melt or deform, creating a risk of an electrical short circuit or a total power failure of the diagnostic system during clinical use.
Manufacturer Notification and Device Support
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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