Events

Recall of Access 2 Immunoassay Systems(Includes the Access 2 Immunoassay System and UniCel DxC 600i Synchron Access Clinical System)An in vitro diagnostic 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-2015-RN-00488-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00488-1
  • 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 updated the instructions for use (ifu) to include the recommended temperature restrictions to address the impact of room temperature changes on certain assays run on access 2 immunoassay systems. the new updated operation range temperatures are between 18 to 28 degrees celsius. an updated version of the ifu is available on the beckman coulter website ( http://www.Beckmancoulter.Com).
  • Action
    Beckman Coulter is notifying their customers that the updated version of the Access 2 Immunoassay Systems IFU is available on the Beckman Coulter website ( http://www.beckmancoulter.com) This action has been closed-out on 19/08/2016.

Device

Access 2 Immunoassay Systems(Includes the Access 2 Immunoassay System and UniCel DxC 600i Synchro...
  • Model / Serial
    Access 2 Immunoassay Systems(Includes the Access 2 Immunoassay System and UniCel DxC 600i Synchron Access Clinical System)An in vitro diagnostic device (IVD)All Serial Numbers All Software Versions
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd