Recall of Radiometer pCO2 membrane (D788) for ABL7/8xx analyzers

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
    15014
  • Event Initiated Date
    2016-11-29
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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
    Possible negative bias on pco2 result on both blood and qc after membrane replacement. this bias can be seen after the replacement of the membrane., update: the temporary countermeasures, regarding the additional requirement for manually narrowing the qc ranges for pco2 and also performing extra qc measurements as communicated in july 2013 are no longer required and may be revoked upon installation of the improved sealing ring on the ph electrodes in abl700 and abl800 series analyzers., 01-02-2017: this notification is to inform you that your radiometer representative has now installed the improved sealing ring for the ph electrode in your abl700 and/or abl800 series analysers.
  • Action
    Manufacturer to issue advice regarding use

Device

Manufacturer