Pre-owned / Used 2015 BIOFIRE DIAGNOSTICS FilmArray 2.0 System PCR Molecular Diagnostics System for Sale

Hardware Summary

Modular, high-throughput PCR system with 96-well capacity, ≤30-minute assay run time, and ≤15-minute sample prep. Features closed-tube, real-time PCR with 99.

Software Summary

BioFire’s FilmArray 2.0 Software Suite includes FDA-cleared, rule-based interpretation algorithms for 30+ validated panels (e.g., BPCO, Gastrointestinal, Respiratory, Mening...

Accessories Summary

Compatible with BioFire’s proprietary Smart Cards (pre-loaded with lyophilized reagents) and standard 96-well plates. Includes automated sample lysis module, barcode scanner...

Hardware

The FilmArray 2.0 System is a fully automated, cartridge-based PCR platform designed for high-volume clinical microbiology labs, featuring a dual-core processor with 16GB RAM and 500GB SSD for real-time data processing. The thermal cycler module achieves ±0.1°C precision across 96 independent reaction wells, with optical detection sensitivity of ≤10 CFU/mL for target pathogens. The biological safety enclosure meets NSF/ANSI 49 standards, with HEPA filtration (99.97% efficiency at 0.3µm) and UV-C decontamination for Class II biosafety compliance. Power requirements are 100-240V AC, 50/60Hz, 15A max, with active cooling via dual-fan redundancy to prevent overheating during extended runs. The system’s modular design allows for future panel expansions without hardware upgrades, and its IP54-rated chassis ensures durability in high-traffic lab environments.

Software / Upgrade / OS / Applications / Worklist

The FilmArray 2.0 Software operates on a Windows 10 Enterprise (64-bit) embedded OS with Microsoft SQL Server 2019 for database management. Key features include BioFire’s proprietary FilmArray Torch Software, which employs machine learning-enhanced signal processing to reduce false positives/negatives by >20% compared to conventional PCR. The LIMS integration module supports Epic, Cerner, and Meditech systems via HL7 v2.5.1 and FHIR RESTful APIs, enabling automated result push to EHRs with SNOMED-CT/LOINC coding. The QC dashboard provides real-time reagent lot tracking, instrument calibration logs, and statistical process control (SPC) alerts for CLIA ‘88 compliance. User roles are managed via Active Directory/LDAP, with 256-bit AES encryption for data-at-rest and TLS 1.3 for data-in-transit. The system also includes FDA 510(k)-cleared decision support tools for antimicrobial stewardship, gener...

Accessories

The FilmArray 2.0 System is fully compatible with BioFire’s Smart Cards (e.g., FilmArray BPCO Panel, GI Panel, Respiratory Panel 2+), which contain lyophilized primers/probes and internal controls for end-to-end assay validation. Optional accessories include the FilmArray Lysis Kit (for NAAT sample prep), the FilmArray Barcode Scanner (for sample tracking), and the FilmArray Thermal Cycler Calibration Kit (for ±0.05°C accuracy verification). Third-party consumables must meet ISO 11135 sterility standards and USP <71> microbial limits. The system supports standard 96-well plates for custom research applications, provided they are PCR-grade and DNase/RNase-free. Additional peripherals include a high-resolution 24-inch touchscreen monitor (1920x1200), a thermal printer (80mm width, 240dpi), and a USB 3.0 data port for offline backups.

Warranty Inclusions & Exclusions

The FilmArray 2.0 System is offered with a seller-negotiated warranty, typically structured as follows: 1-year limited hardware warranty covering defective components (excluding consumables) with next-business-day RMA processing. The warranty includes on-site calibration services (annual) and 24/7 technical support via BioFire’s global service network. Software updates are provided quarterly at no additional cost, with priority patches for critical security vulnerabilities (CVE-rated). Extended warranty options (up to 3 years) may include preventive maintenance visits, reagent compatibility guarantees, and priority access to BioFire’s clinical consultation team. Refunds or returns are subject to restocking fees (20-30%) and condition verification by a BioFire-certified technician. Shipping for warranty claims is the buyer’s responsibility, with FedEx/UPS accounts provided for large components.

Service History

This pre-owned FilmArray 2.0 System has undergone comprehensive refurbishment by a BioFire-authorized service provider, including full hardware diagnostics, software revalidation, and calibration to OEM specifications. Key service records include: 12-month preventive maintenance log (last performed 6 months prior to listing), 3 annual calibration cycles (all within ±0.05°C tolerance), and zero reported instrument failures during >5,000 assay runs. The system was previously deployed in a community hospital setting with moderate-volume infectious disease testing (avg. 40 samples/day). Service history documents 100% pass rate for internal control validation and <1% assay failure rate, with all issues resolved via software updates (no hardware replacements). The last software version installed is FilmArray Torch v4.2.1, with full audit trails available upon request.

Packing List

The FilmArray 2.0 System is packaged in its original BioFire shipping crate, which includes the following components: 1x Main Instrument Unit (with pre-installed software), 1x Power Cord (10A, 120V), 1x Ethernet Cable (Cat 6, 10m), 1x USB 3.0 Data Cable, 1x Thermal Printer (with 1 roll of label paper), 1x 24-inch Touchscreen Monitor, 1x User Manual (v3.1, dated 2022), 1x Calibration Certificate (issued 2023), 1x Smart Card Lysis Kit (50 tests), and 1x Barcode Scanner. The crate is secured with anti-static foam padding and corner guards for IATA-compliant air freight. Additional packaging includes 2x Reagent Storage Boxes (4°C compatible) and 1x Waste Disposal Kit (for Smart Card biohazard containment). The total gross weight is ~120 kg, with dimensions (LxWxH) of 70 x 60 x 75 cm for the main unit.

Additional Information

The FilmArray 2.0 System is FDA 510(k)-cleared (K161047) for in vitro diagnostic (IVD) use and holds CE-IVD certification (MDD 98/79/EC) for European markets. It complies with CLIA ‘88 moderate-complexity testing, ISO 15189:2012, and ISO 13485:2016 for quality management systems. The system is validated for use with ≥30 BioFire panels, covering bacterial, viral, fungal, and parasitic infections, with ≥95% sensitivity and ≥99% specificity for FDA-cleared assays. Clinical applications include hospital-acquired infection surveillance, outbreak response, and antimicrobial stewardship programs. The FilmArray 2.0 has been peer-reviewed in JAMA, Clinical Infectious Diseases, and EuroSurveillance, demonstrating 30-50% reduction in turnaround time compared to traditional culture methods. Integration with hospital information systems (HIS) enables real-time sepsis alerts and automated infection control notifications. Safety features include fail-safe power loss protocols, reagent expiration tracking, and automated error correction for ≥90% of common user inputs. The system is not compatible with homebrew assays or non-BioFire Smart Cards without additional validation. For research use only (RUO), custom panels require CLIA-waived lab certification.