• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall enGen TM Laboratory Automation System

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
 Class 2 Recall
enGen TM Laboratory Automation System
see related information
Date Posted March 28, 2011
Recall Status1 Open
Recall Number Z-1831-2011
Recall Event ID 57887
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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.)
Code Information 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
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester, New York 14626
For Additional Information Contact Joseph Falvo
Manufacturer Reason
for Recall
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.
Action The firm, Ortho Clinical Diagnostics (OCD), sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated January 27, 2011, by Federal Express overnight mail to all customers. Foreign affiliate consignees/customers were notified by email informing them of the issue on the same day. The letter described the problem, product and actions to be taken. The firm also included temporary procedures to help prevent the occurrence of the software anomaly. The customers were instructed to follow the enclosed Procedure to STOP the Automation System and/or Bypass Module; complete and return the attached Confirmation of Receipt - Important Response Required form by February 4, 2011, via fax to: Ortho Clinical Diagnostics, 1-888-557-3759 or 1-585-453-4110, and display this communication near the enGen Laboratory Automation System to ensure compliance by all operators until updated TCAutomation Laboratory Automation System software is installed. A Technical Bulletin will be sent to customers in the near future to be stored with user documentation. Ortho will implement a TCAutomation Laboratory Automation System software change in the near future to resolve this anomaly. If you have any questions regarding this notification, please call Customer Technical Services at 1-800-421-3311 (Options 1, 2).
Quantity in Commerce 63 units
Distribution Worldwide distribution: USA and countries including: Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55