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
    87785
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-25
  • 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
    If the abl90 flex analyzer is tilted it may cause a negative bias on sodium results up to 7% (minus 10mm). this issue has been reported when the analyzer has been installed on a roll stand and tilted (i.E. the support plate is not horizontal).

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.