FilmArray TORCH REF HTFA-ASY-0104 — Class II medical device recall Z-0353-2024
Ongoing recall by BioFire Diagnostics, LLC, reported 2023-11-29, distributed nationwide. Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power sw
| Recall number | Z-0353-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2023-10-17 |
| Classified | 2023-11-20 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BR, CA, CL, CN, CO, CR, CZ, DE, DZ, EG, ES, FR, GT, ID, IN, IT, JP, KR, KW, MX, MY, NZ, PH, PL, PY, QA, RO, SA, SG, SV, TR, TW |
| Quantity | 5,406 systems |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00815381020253 |
| Serial numbers | 02972, KTB00001, KTB00002, KTB00003, KTB00004, KTB00005, KTB00006, KTB00007, KTB00008, KTB00009, KTB00011, KTB00012, KTB00013, KTB00014, KTB00015, KTB00016, KTB00017, KTB00018, KTB00019, KTB00020, KTB00021, KTB00022, KTB00023, KTB00025, KTB00026 and 475 more |
| Model numbers | HTFA-ASY-0104 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0353-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.