Events

Recall of AUTOCHECK 5+

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
    51914
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-28
  • 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 autocheck 5+ level 2 ampoules may give incorrect results for po2. a defective qc ampoule may for po2 give a considerable higher result than the expected assigned value of 13.9 - 14.3 kpa (104-107 mmhg).

Device

AUTOCHECK 5+
  • Model / Serial
    Model Catalog: S7745 (Lot serial: R0689)
  • Product Description
    AUTOCHECK 5+
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS