Company: Ortho-Clinical Diagnostics.
Date of Enforcement Report 4/13/2011
Class ll:
PRODUCT
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.) Recall # Z-1831-2011
REASON
A software anomaly that can occur with analyzers connected to the Bypass modules listed below on an enGen” Laboratory Automation System using TCAutomation” Software Version 3.1.1 and below. When this anomaly occurs, it is possible for a sample other than the intended sample to be aspirated, potentially leading to test results being assigned to the wrong patient without error notification.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by letter dated January 27, 2011.
Manufacturer: Thermo Electron Oy, Vantaa, Finland. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
63 units
DISTRIBUTION
Nationwide and Internationally
