Pre-owned / Used 2020 BIOFIRE DIAGNOSTICS FilmArray Torch PCR Molecular Diagnostics System for Sale

Hardware Summary

Integrated 8-well sample processing system with automated thermal cycling, 1.5-hour turnaround time, and 0.2°C temperature control precision for high-throughput molecular diagnostics.

Software Summary

FilmArray Torch System Software v2.0 with FDA-cleared, CE-IVD marked assays, cloud-based data management, and LIS/EHR bidirectional integration for seamless workflow automation.

Accessories Summary

Compatible with FilmArray Pouch Multiplex ID Panels, extraction kits, calibration standards, and BioFire Security Software for HIPAA-compliant data handling and audit trails.

Hardware

The FilmArray Torch is a compact, benchtop molecular diagnostic system engineered for automated nucleic acid extraction, reverse transcription, and real-time PCR amplification. The system features an integrated 8-well reaction module with independent thermal control for each well, achieving ±0.2°C temperature uniformity across the 50–95°C range. The device incorporates a high-resolution fluorescence detection system with a 4-channel optical reader (470/520/580/660 nm excitation/emission wavelengths) for multiplex pathogen detection. Connectivity includes dual USB 3.0 ports, Gigabit Ethernet, and Wi-Fi 802.11ac for laboratory information system (LIS) integration. The system operates on 100–240V AC power with a universal input range and consumes <150W during active processing. Physical dimensions are 30.5 cm (W) x 40.6 cm (D) x 30.5 cm (H), with a total weight of 12.7 kg, designed for Class II, Type B biological safety cabinet compatibility.

Software / Upgrade / OS / Applications / Worklist

The FilmArray Torch System Software v2.0 operates on a proprietary Linux-based embedded OS with a touchscreen interface for intuitive user interaction. The software supports FDA-cleared assays including the FilmArray Respiratory Panel, Blood Culture Identification Panel, and Gastrointestinal Panel, with additional custom assay development capabilities. Data output includes Ct values, melting curves, and qualitative/quantitative results with automatic interpretation algorithms. The system integrates with hospital LIS/EHR platforms via HL7 or FHIR standards, enabling bidirectional data exchange for patient result reporting and inventory management. Security features include role-based access control, audit logging, and encryption of stored data in compliance with HIPAA and GDPR regulations. The software supports remote diagnostics via secure VPN connection, with automatic software updates delivered through BioFire's cloud-based update service.

Accessories

The FilmArray Torch ecosystem includes a comprehensive range of consumables and accessories designed for seamless integration into clinical workflows. Primary consumables include FilmArray Pouch Multiplex ID Panels (e.g., RP2.1 for respiratory pathogens, BCID2 for bloodstream infections, and GI Panel for gastrointestinal pathogens), each containing lyophilized reagents for 12 targets per pouch. Additional consumables include FilmArray Extraction Kit v2.0 for nucleic acid purification, FilmArray Calibration Kit for instrument performance verification, and FilmArray Waste Bags for biohazardous material disposal. The system is compatible with third-party sample collection tubes (e.g., BD Vacutainer, Greiner Bio-One) and pre-analytical systems such as the FilmArray Sample Prep Station for automated sample processing. For data management, BioFire Security Software provides HIPAA-compliant data encryption, audit trails, and role-based access control.

Warranty Inclusions & Exclusions

This pre-owned FilmArray Torch system is offered with a comprehensive warranty package designed to provide peace of mind and operational continuity. The seller provides a 12-month limited warranty covering defects in materials and workmanship, including replacement of critical components such as the thermal cycler module, optical detection system, and embedded computer. Extended warranty options are available for an additional fee, including a 24-month comprehensive package that covers labor, parts, and on-site service visits. The warranty includes 24/7 technical support via phone and email, with a guaranteed response time of <4 business hours for critical issues. On-site service is available through BioFire Diagnostics' authorized service network, with certified technicians providing calibration, preventive maintenance, and troubleshooting. The warranty excludes consumables (e.g., pouches, extraction kits) and damage resulting from misuse, improper installation, or unauthorized mod...

Service History

This FilmArray Torch system has been meticulously maintained with a documented service history, ensuring optimal performance and compliance with manufacturer guidelines. The system underwent its first preventive maintenance (PM) service at 12 months of operation, including calibration of the thermal cycler, verification of optical detection accuracy, and replacement of HEPA filters. Subsequent PM services were performed at 24 and 36 months, with detailed records confirming compliance with ISO 13485:2016 standards. The system has been calibrated using FilmArray Calibration Kit v2.0, with Ct value deviations maintained within ±0.5 cycles for all channels. No major component failures or unplanned downtime have been recorded, and the system has consistently passed BioFire Diagnostics' performance verification tests. The optical detection system has been serviced at 24 months to address minor drift in fluorescence intensity, with recalibration restoring performance to manufacturer specif...

Packing List

The FilmArray Torch system is provided in its original packaging, including the benchtop unit, power cable, Ethernet cable, USB cable, and quick-start guide. The system is secured within a custom-molded foam insert inside a durable corrugated shipping carton measuring 50.8 cm (W) x 61.0 cm (D) x 50.8 cm (H), with a total weight of 25 kg. Accessories included in the shipment are the FilmArray Sample Prep Station, FilmArray Waste Bags (box of 50), FilmArray Calibration Kit v2.0, and a set of FilmArray Pouch Multiplex ID Panels (RP2.1, 10 pouches). Additional components include a spare HEPA filter, a set of calibration standards, and a BioFire Security Software license key. The packing list is accompanied by a detailed inventory checklist, shipping manifest, and a certificate of conformity confirming the system's condition and compliance with ISO 13485:2016 standards. All components are packed in compliance with ISTA 3A packaging standards for medical devices, ensuring protection again...

Additional Information

The FilmArray Torch is a Class II medical device cleared by the FDA under 510(k) K163546 and CE-marked under IVDR 2017/746, designed for in vitro diagnostic use in clinical laboratories and point-of-care settings. The system is compatible with a wide range of biological samples, including nasopharyngeal swabs, sputum, blood culture bottles, stool samples, and cerebrospinal fluid, with validated protocols for pathogen detection across respiratory, bloodstream, gastrointestinal, and central nervous system infections. Clinical performance metrics include a sensitivity of >95% and specificity of >99% for FDA-cleared assays, with a limit of detection (LoD) as low as 10^2–10^3 copies/mL depending on the target pathogen. The system operates in compliance with ISO 18113-1:2022 (in vitro diagnostic medical devices – information supplied by the manufacturer), ISO 23640:2015 (stability testing of in vitro diagnostic reagents), and CLSI EP17-A2 (evaluation of detection capabilities for clinical laboratory measurement procedures). Electrical safety is certified to IEC 60601-1:2005+A1:2012, with electromagnetic compatibility (EMC) compliance to IEC 60601-1-2:2014 for use in healthcare facilities. The system is designed for use in BSL-2 environments and includes safety features such as automatic shutdown in case of overheating, door interlocks, and biohazard containment. Integration capabilities include HL7 v2.5.1 messaging for LIS/EHR systems, DICOM support for radiology workflows, and API access for custom software development. The system is compatible with major hospital information systems, including Epic, Cerner, and Meditech, enabling seamless result reporting and inventory management. Environmental operating conditions include a temperature range of 15–30°C, humidity of 20–80% non-condensing, and altitude up to 2,000 meters.