Events

Recall of enGen Laboratory Automation 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-2015-RN-00328-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00328-1
  • 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) is advising users of a software anomaly regarding the routing of urine samples which required pre-treatment for assays using vitros chemistry products ca, mg and phos slides. the engen system software currently does not route samples which require acidification pre-treatment to the manual high priority exit location for pre-treatments as intended. in addition, the engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pre-treatment. ocd internal testing has confirmed instances where vitros 5,1 fs, 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen, regardless of the pre-treatment requirements for each selected assay, potentially leading to biased patient results.
  • Action
    OCD is providing temporary work around instructions for users to prevent the failure mode. A software update will be implemented as a permanent fix. Also, OCD is advising users to discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 11/08/2016.

Device

enGen Laboratory Automation Systems, An in vitro diagnostic medical device (IVD)
  • Model / Serial
    enGen Laboratory Automation Systems, An in vitro diagnostic medical device (IVD)Affected Versions: Systems configured with enGen Select v5.0 and Custom or Select v3.2.2 and belowProduct Code: ENGEN
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics