Events

Recall of enGen Laboratory Automation Systems (enGen) with TCAutomation Software v2.6, v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems (an in vitro diagnostic medical device (IVD))

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia 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
    RC-2014-RN-00485-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00485-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Ortho clinical diagnostics (ocd) determined that, due to a software timing issue, a sample tube carrier being released in the bypass module may not be detected, potentially resulting in the next sample to be metered not advancing for processing. no error message will be posted if this occurs. the bypass module will stop processing samples indefinitely until an operator detects the issue and intervenes.
  • Action
    Ortho-Clinical Diagnostics will provide a resolution for this issue in a future software version. In the interim, end users are requested to routinely monitor the Bypass module for stoppage due to the software timing issue. This action has been close-out on 11/02/2016.

Device

enGen Laboratory Automation Systems (enGen) with TCAutomation Software v2.6, v3.2 and v3.5 Config...
  • Model / Serial
    enGen Laboratory Automation Systems (enGen) with TCAutomation Software v2.6, v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems (an in vitro diagnostic medical device (IVD))Multiple affected bypass modules (product codes)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics