Recall Z-0353-2024 ยท NSU Instrumentation For Clinical Multiplex Test Systems
BioFire Diagnostics, LLC
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 TO
| Date | Nov 20, 2023 (initiated Oct 17, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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 |
| Quantity | 5,406 systems |
| Distribution | 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 W |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.