Events

Recall of enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) v8.06

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-00414-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00414-1
  • 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
    The engen laboratory automation system is an automated track which integrates clinical analysers and the customer’s lis (laboratory information system). it centrally controls pre-analytical and post-analytical processing as well as sample transport to multiple independent analysers and devices. ortho clinical diagnostics (ocd) internal testing has determined that when a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (storage) prior to the completion of the necessary pending action. a delay in patient test result(s) reporting could occur.
  • Action
    Laboratories are advised to manually rerun samples that have been prematurely stored. A software modification is currently in development and will be provided once complete. This action has been closed-out on 11/02/2016.

Device

enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) ...
  • Model / Serial
    enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) v8.06Product Code: 6802883Lot Numbers: enGen Select Versions 3.2.2 and below & enGen Custom versions 3.2.2 and below
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics