Events

Recall of ENGEN AUTOMATED SAMPLE HANDLING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada 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
    16662
  • Event Risk Class
    II
  • Event Initiated Date
    2011-01-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Ortho clinical diagnostics has identified a software anomaly that can occur with analyzers connected to the bypass modules listed 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.

Device

ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Model / Serial
    Model Catalog: ENGEN (Lot serial: JCT20Q3J); Model Catalog: ENGEN (Lot serial: J16XQH4J)
  • Product Description
    ENGEN LABORATORY AUTOMATION SYSTEMS
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS