Events

Recall of ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). 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 Radiometer Pacific 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-00805-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00805-1
  • 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
    Radiometer has recently become aware of a potential issue where a battery module had overheated caused by the continued charging of a collapsed battery cell. they have identified that worn battery modules with limited or no capacity manufactured in production runs below 910-311p0009nxxx are prone to cell collapses.
  • Action
    Radiometer is advising users that battery modules below 910-311P0009Nxxx will be replaced with a newly designed battery module. Radiometer is advising users with battery modules 910-311P0009Nxxx and above will be required to undertake 12 monthly checks of the capacity of the battery modules. This action has been closed-out on 11/08/2016.

Device

ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An...
  • Model / Serial
    ABL90Flex battery module used with Radiometer ABL90FLEX blood gas analyser (Optional battery). An in vitro diagnostic medical device (IVD)Battery modules: below 910-311P0009NxxxAll serial numbers affectedARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd