Events

Recall of ABL80 FLEX CO-OX - INSTRUMENT

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
    24741
  • Event Risk Class
    II
  • Event Initiated Date
    2010-01-10
  • 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 during patient sample measurement the (thb) parameter is not selected for reporting then any results reported for the fractional hemoglobin parameters (so2 fo2hb fcohb fmethb and fhhb) will be values taken from a prior measurent and not associated with the current patient measurement.

Device

ABL80 FLEX CO-OX - INSTRUMENT
  • Model / Serial
    Model Catalog: 393-841 (Lot serial: 302238); Model Catalog: 393-841 (Lot serial: 302018 302021 302023302025); Model Catalog: 393-841 (Lot serial: 302100 302140 302178-79); Model Catalog: 393-841 (Lot serial: 302080-81-82 302092-93-98); Model Catalog: 393-841 (Lot serial: 302069-70 302070-72-74-76-79)
  • Product Description
    ABL80 FLEX CO-OX system softw.1.301.31
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS