Events

Recall of Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical System). 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 Beckman Coulter Australia Pty Ltd.

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-01087-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01087-1
  • 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
    Beckman coulter has determined that the access 2 console pc (b23083) may experience an “mfc exception” error during normal operation. if this error occurs, the system will exit the access 2 user interface (ui) screen and display a window that notifies the user of a “0==itubescancount” event. if the ui is re-launched, the system will prevent access to the sample manager screen to request samples for processing and the same “mfc exception” error will occur. the access 2 console pc ui error can cause a delay in reporting of results, but will not cause erroneous results.
  • Action
    Beckman Coulter service representative will contact affected customers and schedule a service visit to modify their Console PC. In the interim, customers are advised to continue operating their systems normally and contact Beckman Coulter Customer Support Centre if the error occurs. This action has been closed-out on 20/04/2017.

Device

Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON A...
  • Model / Serial
    Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical System). An in vitro diagnostic medical device (IVD)Ref.: B23083 (small PC with silver faceplate)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd