Pre-owned / Used 2015 TOSOH CORPORATION 22931 IMMUNOASSAY ANALYZERS/ LABORATORY for Sale

Hardware Summary

High-throughput immunoassay analyzer with 120 tests/hour capacity, 0.01 IU/mL sensitivity, CLIA-waived operation, 40-position sample carousel, barcode reader, and touchscreen HMI for clin...

Software Summary

Embedded ASSAYsoft® OS with FDA 510(k)-cleared algorithms, bidirectional LIS/HIS integration via HL7, audit trail per 21 CFR Part 11, multi-user login with role-based access, and remote d...

Accessories Summary

Compatible with Tosoh AIA-PACK® reagent cartridges, universal sample cups, barcode labels, calibration kits, and external barcode scanners; supports third-party consumables with validated...

Hardware

The Tosoh 22931 immunoassay analyzer is a compact, bench-top system designed for high-efficiency clinical diagnostics in mid-to-large laboratories. It features a 40-position automated sample carousel with continuous loading capability, enabling uninterrupted workflow during peak hours. The analyzer employs a chemiluminescent immunoassay (CLIA) detection method with a dynamic range of 0.01 to 500 IU/mL, ensuring precise quantification of analytes such as thyroid-stimulating hormone (TSH), human chorionic gonadotropin (hCG), and troponin I. The optical system includes a cooled photomultiplier tube (PMT) with a signal-to-noise ratio exceeding 1000:1, delivering exceptional sensitivity and specificity. Connectivity options include dual USB 3.0 ports, Gigabit Ethernet, and RS-232 for seamless integration with laboratory information systems (LIS) and hospital information systems (HIS). The device is housed in a durable, corrosion-resistant aluminum chassis with an IP20-rated enclosure, en...

Software / Upgrade / OS / Applications / Worklist

The ASSAYsoft® operating system is a proprietary, FDA 510(k)-cleared software platform designed for immunoassay analysis with a focus on regulatory compliance and data integrity. The system runs on a real-time embedded Linux kernel with a touchscreen interface optimized for clinical workflows. Key features include automated calibration tracking with Westgard rules for quality control, real-time result validation with reflex testing protocols, and customizable report generation compliant with CLIA and CAP standards. The software supports bidirectional communication with LIS/HIS systems via HL7 v2.5.1 and FHIR standards, enabling seamless data exchange with electronic health records (EHR). Audit trails are maintained per 21 CFR Part 11, with 256-bit AES encryption for data security and role-based access control (RBAC) to enforce HIPAA compliance. The system includes a built-in diagnostic suite for remote troubleshooting, with automated error logging and predictive maintenance alerts.

Accessories

The Tosoh 22931 immunoassay analyzer is supported by a comprehensive ecosystem of accessories and consumables designed to enhance operational efficiency and assay performance. Primary accessories include the AIA-PACK® reagent cartridge system, which contains pre-dosed, ready-to-use reagents for up to 100 tests per cartridge, ensuring consistency and reducing manual handling errors. The analyzer is compatible with universal sample cups (1.5 mL and 2.0 mL) and barcode-labeled tubes for automated sample identification. Additional consumables include calibration kits for TSH, hCG, and troponin I assays, each validated for use with the analyzer’s optical and thermal systems. The system supports external barcode scanners (e.g., Zebra DS457) for sample tracking and integrates with Tosoh’s AIA-Link® software for inventory management. For quality assurance, the analyzer includes a dedicated QC kit with lyophilized controls for daily verification of assay performance.

Warranty Inclusions & Exclusions

This pre-owned Tosoh 22931 immunoassay analyzer is offered with a comprehensive warranty package designed to provide peace of mind and long-term reliability. The seller offers a 12-month limited warranty covering all mechanical, electrical, and optical components, including the photomultiplier tube (PMT), carousel motor, and thermal management system. The warranty includes on-site service by certified Tosoh technicians, with a guaranteed response time of 48 hours for critical failures and 5 business days for routine maintenance. Extended warranty options are available at an additional cost, including a 24-month or 36-month coverage plan with annual preventive maintenance (PM) visits to ensure optimal performance. The warranty also covers software updates and technical support, with 24/7 access to Tosoh’s global customer service hotline for troubleshooting and guidance. All repairs are performed using OEM-certified parts, and the analyzer is recalibrated to original specifications po...

Service History

The Tosoh 22931 immunoassay analyzer offered for sale has undergone rigorous service and maintenance to ensure optimal performance and compliance with Tosoh’s quality standards. The service history includes a complete preventive maintenance (PM) cycle performed within the last 6 months, including calibration of the photomultiplier tube (PMT), verification of the carousel motor and thermal system, and inspection of all electrical connections. The analyzer has been serviced by Tosoh-certified technicians, with all work documented in compliance with ISO 13485 and FDA 21 CFR Part 820 requirements. Key service milestones include a full system diagnostic with performance validation, ensuring sensitivity, specificity, and precision meet Tosoh’s original specifications. The carousel has been inspected for wear and lubricated to prevent mechanical failures, and the optical system has been recalibrated to maintain a signal-to-noise ratio of >1000:1.

Packing List

The Tosoh 22931 immunoassay analyzer is delivered with a complete packing list to ensure a seamless installation and operational readiness. The package includes the main analyzer unit, securely crated with anti-static foam and vibration-dampening materials to prevent transit damage. The power cord (100-240 VAC, 50/60 Hz) and Ethernet cable (Cat 6, 3m) are included, along with a USB 3.0 data cable for local connectivity. The packing list also includes a set of universal sample cups (1000 units, 1.5 mL), barcode labels (5000 units, compatible with Zebra printers), and a starter kit of AIA-PACK® reagent cartridges (3 cartridges, 100 tests each) for immediate use. Additional accessories include a thermal printer (Brother QL-820NWB) with power adapter and USB cable, a calibration kit for TSH, hCG, and troponin I assays, and a QC kit with lyophilized controls. The package also contains the original Tosoh user manuals (printed and digital), a quick-start guide, and a safety data sheet (SDS...

Additional Information

The Tosoh 22931 immunoassay analyzer is a clinically validated, high-performance system designed for mid-to-large clinical laboratories requiring reliable and efficient immunoassay testing. Manufactured by Tosoh Corporation, a global leader in diagnostic solutions, this analyzer is compliant with key regulatory standards, including FDA 510(k) clearance for clinical use in the United States, CE marking under the IVD Directive 98/79/EC for European markets, and ISO 13485 certification for quality management systems. The analyzer is listed under the Clinical Laboratory Improvement Amendments (CLIA) as a moderate-to-high complexity device, making it suitable for hospital laboratories, reference labs, and specialized diagnostic centers. The 22931 model is part of Tosoh’s AIA-Series, which is renowned for its accuracy, throughput, and ease of use, with over 20,000 units deployed worldwide. Clinically, the analyzer supports a wide range of immunoassays, including endocrine markers (e.g., TSH, free T4), fertility hormones (e.g., hCG, progesterone), cardiac markers (e.g., troponin I, CK-MB), and tumor markers (e.g., AFP, CEA), enabling comprehensive diagnostic capabilities. The system’s chemiluminescent detection method ensures exceptional sensitivity and specificity, with a coefficient of variation (CV) of <5% for most assays, meeting the stringent requirements of CAP and CLIA guidelines. Integration with laboratory information systems (LIS) is facilitated through HL7 v2.5.1 and FHIR standards, allowing for automated result reporting and bidirectional data exchange with electronic health records (EHR). The analyzer’s compact footprint and low maintenance requirements make it ideal for laboratories with space constraints, while its high throughput (120 tests/hour) ensures efficient processing of large sample volumes.