Events

Recall of 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
    23011
  • Event Initiated Date
    2018-05-23
  • 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 abl90 flex in a very rare specific situation can aspirate cal 2 solution instead of rinse solution., the specific situation can occur when the following take place:, 1. the analyzer is in ready mode, 2. operator lifts the inlet and then closes it again, thereby initiating a rinse, 3. immediately after lifts the inlet and quickly closes it again.
  • Action
    Software to be upgraded

Device

ABL90Flex analyser
  • Model / Serial
    Model: All analysers with software version 3.3MR1 or lower, Affected:
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS