Events

Recall of Device Recall enGen TM Laboratory Automation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho-Clinical Diagnostics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57887
  • Event Risk Class
    Class 2
  • Event Number
    Z-1831-2011
  • Event Initiated Date
    2011-01-27
  • Event Date Posted
    2011-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97672
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 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.
  • 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).

Device

Device Recall enGen TM Laboratory Automation System
  • Model / Serial
    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
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.
  • Product Description
    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.)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA