Events

Recall of Radiometer ABL800 series

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

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
    23285
  • Event Initiated Date
    2018-07-03
  • 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
    The manufacturer has recently become aware that the abl800 analysers that measure ccrea may potentially report lower than expected ccrea results on patient samples., the difference has been reported to be as high as -28%., currently, this problem may not be caught by running qc, as the qc will be lower, but still within range.
  • Action
    Manufacturer to issue advice regarding use

Device

Radiometer ABL800 series
  • Model / Serial
    Model: Radiometer ABL800 series blood gas anlaysers measuring cCrea, Affected:
  • Manufacturer
    Radiometer Basel AG

Manufacturer

Radiometer Basel AG