Events

Recall of VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. 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-2016-RN-01254-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-09-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01254-1
  • 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 has become aware that there is the potential for test results to be mis-associated with the wrong sample id (sid) and to be reported prior to the tcautomation system detecting a sid mismatch. this mis-match may occur when the centrifuge module fails to grip the sample tube when attempting to unload the centrifuge.The system will generate an error message for the unload failure, however the centrifuge will continue to operate as normal. the sample rack containing the sample that has not been unloaded will be transferred back to the load side of the centrifuge, and the system will not recognise that the sample is still in the rack. this may result in the sample being re-analysed and the sid being mis-associated. assay results are potentially associated with the wrong patient and may be reported. this could lead to misdiagnosis or inappropriate treatment of a patient. ortho received no reports of patient injury due to this issue.
  • Action
    Ortho is advising users to check samples associated with Cross Check errors when they appear on the TAC error messages screen, and to ensure preventative maintenance and cleaning procedures for the centrifuge are carried out as required. Past occurrences of this issue are not easily identifiable, and a review of previous results may be impractical. Ortho is recommending users discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 18/05/2017.

Device

VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. An in vitro di...
  • Model / Serial
    VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. An in vitro diagnostic medical device (IVD)VITROS Automation Solutions with TCAutomation System (TAC)Product Code: 6844300Software version: 3.6.2 and belowThermo Scientific Centrifuge ModuleProduct Code: 952040ARTG Number: 229946
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics