Events

Recall of AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. 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-2012-RN-01140-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01140-1
  • 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
    If the au5800 diluted detergent tank valve is not positioned to 'closed' during the instrument 'measure' mode, diluted detergent will not be dispensed and may adversely affect washing of cuvettes, probes and mixing-bars. inadequate washing of cuvettes, probes and mixing bars can cause falsely high or low results to be reported for a variety of tests.
  • Action
    Beckman Coulter is providing work around instructions to mitigate the issue and is asking customers to add a label to the diluted detergent tank identifying the "Open" and "Closed" orientation of the valve.

Device

AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. An in vitro diagnosti...
  • Model / Serial
    AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. An in vitro diagnostic medical device (IVD)Multiple models and catalogue numbersAll serial numbers affected
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd