Events

Recall of Radiometer ABL90Flex analyser

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Radiometer Medical ApS.

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
    17922
  • Event Initiated Date
    2014-12-24
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Reason
    Manufacturer has become aware of a potential significant clinical issue with patient results if the inlet is left open after aspiration of the patient sample for more than 30 seconds., note that if the inlet is accidentally left open after processing a patient sample the abl90 analyser sounds a warning bell, places a warning message on the screen and also initiates a voice message continuously repeating "please close the inlet"., the problem can occur after the following sequence of actions:, 1.The operator aspirates patient sample a and forgets to close the inlet, 2.The inlet is left open for more than 30 seconds before it is closed, 3.An operator aspirates patient sample b, in this case the results for patient sample b are affected by this issue.
  • Action
    Instructions for use to be updated

Device

Radiometer ABL90Flex analyser

Manufacturer

Radiometer Medical ApS