Events

Recall of ABL5

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
    105567
  • Event Risk Class
    III
  • Event Initiated Date
    2013-05-21
  • 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 identified that one lot of membrane boxes has been produced using an incorrect electrolyte solution. the incorrect solution causes the sensitivity of the pco2 electrode to be very low for which reason the calibration fails and results cannot be reported.

Device

ABL5
  • Model / Serial
    Model Catalog: 391-793 (Lot serial: N/A)
  • Product Description
    D888 Membrane Box pCO2 for ABL5/50/5XX
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS