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Open, Classified

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 approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.

FDA Recall Z-0353-2024 · Posted 2023-11-20

Recalling FirmBioFire Diagnostics, LLC
Recall StatusOpen, Classified
Product CodeNSU
Date Initiated2023-10-17
Product Quantity5,406 systems

Reason for Recall

Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.

Firm Action

On 10/17/2023, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via FedEx overnight informing customers that bioMerieux has identified an increased risk of degradation of the poser entry switch of the TORCH base. This increase risk may be seen on systems that are power cycled (shutting down the system and then turning it on again) frequently. When turning on BIOFIRE TORCH systems, arcing inside of the power switch may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use. Customer are being instructed to: 1.If a user determines that the BIOFIRE TORCH Base requires complete shutdown, each individual BIOFIRE TORCH module must be powered down prior to turning on the BIOFIRE TORCH Base, 2. Reset the BIOFIRE TORCH Base weekly using the Reset button, and 3.Please complete the accompanying Acknowledgment of Receipt Form and return it to bioMerieux so that bioMerieux may acknowledge your receipt of this notification. Please contact customer support at [email protected] or via telephone by dialing +1.800.736.6354 and selecting option 5 for Product Technical Support with any questions or concerns.

Root Cause

Device Design

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, N, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Philippines, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, United Arab Emirates.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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