Events

Recall of AU2700/AU2700 Plus and AU5400 Clinical 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-2013-RN-00402-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00402-1
  • 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 implemented a redesigned detergent tube, replacing the tubing with a more pliable material to allow for easier insertion to the detergent tank. new complaints that the joint connecting the tubing is disintegrating over time have been received. disintegration of the tubing/joint has the potential to result in detergent leaks.
  • Action
    Beckman Coulter has requested their customers to implement work around maintenance procedures until a new tubing design can be implemented. Customers are also requested to discontinue use of the analyser and contact Beckman Coulter immediately if a leak occurs.

Device

AU2700/AU2700 Plus and AU5400 Clinical Chemistry Analysers, an in vitro diagnostic medical device...
  • Model / Serial
    AU2700/AU2700 Plus and AU5400 Clinical Chemistry Analysers, an in vitro diagnostic medical device (IVD)(Customers with modifications AU2700-184, AU5400-190 Complete)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd