Events

Recall of Radiometer ABL800 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
    21056
  • Event Initiated Date
    2017-04-06
  • 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 abl800 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. an operator or clinician who is aware that the sample types that can be selected on abl800 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., followup april 2017: the final solution to this issue is an upgrade of the abl800 software to software version 6.17 or higher. this new version ensures that cord blood arterial and cord blood venous are transmitted correctly to a his/lis or a middleware system.
  • Action
    Manufacturer to issue advice regarding use

Device

Radiometer ABL800 series blood gas analysers
  • Model / Serial
    Model: , Affected: All connected to HIS/LIS or middleware Data Management system
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS