Events

Recall of ABL90 FLEX - ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RADIOMETER AMERICA INC..

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
    102189
  • Event Risk Class
    II
  • Event Initiated Date
    2016-09-06
  • 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
    It has been discovered that the feature "exit conditioning" may cause a risk to patients. when a new sensor cassette is installed the analyzer will automatically run extra calibrations and internal qc's for the first 24 hours. it is possible during sensor cassette start-up to press "exit conditioning". this will cancel the second start-up calibration and the 3 start-up qc's. it will not affect the remaining frequent calibrations. the analyzer does not indicate the exit from the conditioning and the patient results are not flagged for qc not being run.

Device

ABL90 FLEX - ANALYZER
  • Model / Serial
    Model Catalog: 393-090 (Lot serial: N/A)
  • Product Description
    ABL90 FLEX - ANALYZER
  • Manufacturer
    RADIOMETER AMERICA INC.

Manufacturer

RADIOMETER AMERICA INC.