Device Recall enGen TM Laboratory Automation System

enGenTM Laboratory Automation Systems wiht TCAutomation Software Versions 3.1.1 and below.  Parallel Bypass for Vitros 5.1 FS AT (VITROS 5, 1 FS Chemistry System, VITROS 5600 Integrated System and CITROS 3600 Immunodiagnostics System use this bypass)  Parallel Bypass for Vitros 950  Perpendicular Bypass for Vitros 250  Perpendicular Bypass for Vitros 5, 1 FS AT  Parallel Bypass for Advia Centaur  Parallel Bypass for Abbott Architect i2000

Clinical Chemistry and Clinical Toxicology Devices

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Worldwide distribution: USA and countries including: Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.

The enGenTM Laboratory Automation System consists of 3 main components including Instrument Management Subsystem (Instrument Manager), Automated Track Subsystem (TCAutomation) and Configuration File developed by Ortho-Clinical Diagnostics (OCD). The Instrument Manager is a Windows-based software product that operates on a Pentium-class (or higher) PC processor. The instrument management subsystem is capable of connectivity with clinical analyzers, a Laboratory Information Systems (LIS), barcode label printers and other third party devices. The TCAutomation is a pre-analytical and post-analytical sample management system. The configuration file enables operational support of the site specific layout and instrument selection. || The VITROS 5, 1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric Immunoassay methods.)