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
    101180
  • Event Risk Class
    II
  • Event Initiated Date
    2016-09-08
  • 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 (ortho) has initiated this recall pertaining to engen systems configured with a thermo scientific centrifuge module and tcautomation (tca) software versions 3.6.1 and below. ortho became aware of one confirmed instance of test results that were mis-associated with the wrong sample id (sid) and were reported prior to the engen system detecting the sid mismatch. assay results are potentially associated with the wrong patient and reported out of the laboratory. this could lead to inappropriate intervention with the potential for serious injury to the patient. ortho received no reports of patient injury due to this issue.

Device

ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Model / Serial
    Model Catalog: ENGEN (Lot serial: JCT20Q3J); Model Catalog: ENGEN (Lot serial: J16XQH4J); Model Catalog: ENGEN (Lot serial: J41BCY4J); Model Catalog: ENGEN (Lot serial: J953244)
  • Product Description
    enGen Laboratory Automation System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS