Events

Recall of AU480 Clinical Chemistry Analyser - software version 1.81(Systems configured with Closed Channels ONLY)

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-01011-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01011-1
  • 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
    A software defect has been identified on newly installed au480 systems with software version 1.81. the defect may generate incorrect test results for 2 step method assays on au480 systems configured with closed channels. the software defect occurs when edit and then confirm are pressed on the specific test parameters screen of closed channels. the result is that the measuring point-2 settings will be deleted. the measuring point 2 settings are used for sample blank adjustments for 2 step methods.For samples which may have lih (lipemia, icterus, hemolysis) or other interferant, there is a potential for false high results to be calculated for 2 step method assays on closed channels.
  • Action
    A Beckman Coulter FSE will visit each laboratory and change the closed channels to open channels. A set of action steps and associated instructions is also provided in the Customer Letter which Laboratories can use to determine if they have been affected. This action has been closed-out on 22/08/2016.

Device

AU480 Clinical Chemistry Analyser - software version 1.81(Systems configured with Closed Channels...
  • Model / Serial
    AU480 Clinical Chemistry Analyser - software version 1.81(Systems configured with Closed Channels ONLY) Part Numbers: B12183, B11810; B71362ARTG Number: 236636
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd