Events

Recall of DxH 500 Haematology Analyser, with software version 1.0.2. 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-2017-RN-00705-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00705-1
  • 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 has become aware that when the instrument temperature (<18°c to >36.5°c) is exceeded, the dxh 500 allows sample processing and result reporting despite the instructions for use (table 10.4) stating that “the run sample is inaccessible”. results generated in this scenario may be erroneous. additionally:- the message on the results screen/printout reads “instrument temperature” instead of “instrument temperature out of range”- the results are transmitted to the laboratory information system (lis) without the accompanying “instrument temperature out of range” message. using the auto-transmit option could lead to the release of erroneous results to the lis.If the instrument is operating out of the temperature range, the warnings on the screen are ignored and the results used, then:- these cbc, wbc-diff or cbc/wbc-diff results may be erroneous.- if these erroneous results are released to the physician, this could result in inappropriate patient management.
  • Action
    Beckman will be correcting the issue in a future software update. In the interim, the following instructions are provided to users: - When the message “Instrument Temperature Out of Range” or “Instrument Temperature” is displayed on the system or printouts, do not report the patient results. - Ensure the laboratory ambient temperature is within specifications (18°C - 32°C) when processing samples. - Disable the auto-transmit option if there is a potential for the operational temperature to be exceeded. - Consult with your Medical Director to determine if a retrospective review of results is warranted.

Device

DxH 500 Haematology Analyser, with software version 1.0.2. An in vitro diagnostic medical device ...
  • Model / Serial
    DxH 500 Haematology Analyser, with software version 1.0.2. An in vitro diagnostic medical device (IVD)Reference Number: B40601ARTG Number: 208574
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd