FDA Device recall Z-0353-2024
FilmArray TORCH REF HTFA-ASY-0104
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of FilmArray TORCH REF HTFA-ASY-0104 by Biofire Diagnostics, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0353-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-17 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biofire Diagnostics |
| Distribution | US |
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 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.
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.
Identifiers
| code_info | Model/Part Number: HTFA-ASY-0104 UDI-DI Code: 00815381020253 Serial Numbers: All serial numbers (listed below) U.S. KT…Model/Part Number: HTFA-ASY-0104 UDI-DI Code: 00815381020253 Serial Numbers: All serial numbers (listed below) U.S. KTB00006 KTB00007 KTB00008 KTB00009 KTB00011 KTB00012 KTB00014 KTB00015 KTB00016 KTB00017 KTB00018 KTB00019 KTB00020 KTB00021 KTB00022 KTB00023 KTB00025 KTB00026 KTB00027 KTB00029 KTB00030 KTB00031 KTB00032 KTB00033 KTB00034 KTB00035 KTB00036 KTB00037 KTB00038 KTB00039 KTB00040 KTB00041 KTB00044 KTB00045 KTB00046 KTB00053 KTB00056 KTB00058 KTB00059 KTB00060 KTB00061 KTB00062 KTB00063 KTB00064 KTB00065 KTB00066 KTB00068 KTB00069 KTB00070 KTB00071 KTB00072 KTB00073 KTB00074 KTB00075 KTB00076 KTB00077 KTB00078 KTB00079 KTB00082 KTB00083 KTB00084 KTB00085 KTB00086 KTB00087 KTB00088 KTB00089 KTB00090 KTB00091 KTB00092 KTB00093 KTB00094 KTB00095 KTB00101 KTB00105 KTB00107 KTB00108 KTB00110 KTB00119 KTB00120 KTB00121 KTB00122 KTB00123 KTB00124 KTB00125 KTB00126 KTB00128 KTB00129 KTB00130 KTB00131 KTB00132 KTB00133 KTB00134 KTB00135 KTB00136 KTB00137 KTB00139 KTB00140 KTB00142 K |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0353-2024%22
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