Events

Recall of Radiometer ABL90 Series Blood Gas Analysers

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
    21043
  • Event Initiated Date
    2017-01-24
  • 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
    On the abl90 series analyzers the sample type cord blood has been changed into the two sample types cord blood arterial and cord blood venous. this change took place with software version 3.1 mr5. the selected sample type is displayed correctly on the abl90 series analyzer itself. irrespective of the sample type selected on the abl90 series analyzer during sample processing, the analyzer will transmit the less specific sample type cord blood to a his/lis or middleware system., an operator who is aware that the sample types that can be selected on the abl90 series analyzer are cord blood arterial and cord blood venous may notice that a less specific sample type cord blood appears in the his/lis or middleware system., error may in a worst-case scenario lead to minor fetal hypoxic stress not being immediately recognized if the clinician was to use data from the his/lis or middleware system to determine treatment., this may cause a delay of treatment for newvborn infant.
  • Action
    Software to be upgraded

Device

Radiometer ABL90 Series Blood Gas Analysers

Manufacturer

Radiometer Medical ApS