Cobas Integra 800 Manual
Roche Diagnostics has made every reasonable eﬀ ort to ensure that all the information contained in this manual is. COBAS, COBAS INTEGRA. 400/400 plus 800. User Manual Version 2.0 E-3 15 Messages Table of contents Messages General problem-solving techniques This chapter explains how to identify and interpret messages, and suggests ways of. Human Anatomy And Physiology Laboratory Manual. The COBAS INTEGRA 400 plus analyzer is the perfect solution for clinical chemistry testing in laboratories running up to 400 samples per day. Roche - Cobas Integra 800Designed to support you in achieving improved cost efficiency in an environment where the pressure to cut costs is constantly increasin.
Features Designed for accuracy and efficiency• Sample integrity check ensures adequate sample level, clot detection, and dispensing control • 72 onboard assays, including four ISEs, improve efficiency and turnaround time • No manual reagent preparation and minimal calibration • Extended onboard stability helps reduce reagent waste Convenient access, simple operation • Automatic start-up; full menu availability 24 hours a day • Roche’s 5-position rack helps optimize workflow, reduce sample splitting. • Operator-friendly software and automated maintenance.
Class 2 Device Recall COBAS INTEGRA 800 Analyzer Date Initiated by Firm September 16, 2013 Date Posted November 05, 2013 Recall Status Terminated on May 12, 2015 Recall Number Z-0168-2014 Recall Event ID 510(K)Number Product Classification - Product Code Product COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 1, 2, 1, 0 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. Code Information software version 9864.C2 Recalling Firm/ Manufacturer Roche Diagnostics Operations, Inc.
9115 Hague Rd Indianapolis IN For Additional Information Contact Todd Siesky 317-576-3911 Manufacturer Reason for Recall Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof FDA Determined Cause Software Design Change Action Roche sent an Urgent Medical Device Correction letter dated September 16, 2013, to all affected customers. Jd 310a Service Manual. The letter identified the product, the problem, and the action to be taken by the customer. Roche Diagnostics recommends tracking all ISE counters and manually requesting the corresponding Service Actions listed in the notification be monitored until updated software becomes available during Q4 2013. If the affected product was moved to another site, the notification is to be forwarded.
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