Events

Recall of AU480, AU680, AU5800 Chemistry Analysers. 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-2015-RN-01044-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01044-1
  • 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 c cup may crack due to stress (e.G., wear during use), which may lead to coolant leaking from the cup.For cf150420-069 (customer complaint), the c cup cracked and leaked coolant onto the connectors of the pcb underneath the c cup. this resulted in a short-circuit of the pcb and smoke.
  • Action
    Beckman Coulter is inspecting all analysers and will replaced any affected cups.

Device

AU480, AU680, AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    AU480, AU680, AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD)Part Numbers: MF7311 C cupVarious Model Numbers All products manufactured since March 2011ARTG Number: 236636
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd