BioFire FilmArray TORCH power switch may fail from electrical arcing
BioFire FilmArray TORCH diagnostic devices have a power switch that may degrade from internal arcing and carbon buildup, potentially causing electrical short, device overheating, or failure to power on.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a diagnostic device with a potential fire/electrical short hazard. However, no illnesses, injuries, or deaths have been reported in the source text, and the hazard is theoretical rather than realized. Per the rubric, a risk-of-harm product with no reported incidents scores at most 3 (High).
Plain-English summary
BioFire Diagnostics is recalling BioFire FilmArray TORCH diagnostic systems (model HTFA-ASY-0104 and related components) worldwide. The power entry switch in these devices may degrade over time due to internal arcing, causing carbon buildup on the switch contacts.
This carbon buildup can lead to excess heating inside the power switch, potentially deforming the switch case. The deformation may create an electrical short or, alternatively, an open circuit that prevents the device from powering on. These failures would only occur after the device has been in use.
Affected systems include 5,406 units distributed across the United States, Puerto Rico, U.S. Virgin Islands, and internationally to multiple countries. A complete list of affected serial numbers (KTB prefix) is available from the manufacturer. Healthcare facilities should verify their device serial numbers against the recall list.
Users should contact BioFire Diagnostics for instructions. If an affected device is in use and displays any sign of electrical malfunction, it should be taken offline immediately.
The recalled product
- Product
- FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or…
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 5,406
Distribution
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