Events

Recall of ABL90 FLEX - ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada 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
    56321
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Radiometer has recently become aware of a potential significant clinical issue with the results reported if or when the inlet is left open after aspiration of the patient sample for more than 30 seconds.

Device

ABL90 FLEX - ANALYZER
  • Model / Serial
    Model Catalog: 393-090 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    ABL90 FLEX - ANALYZER
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS