Events

Recall of ABL700

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
    22567
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-24
  • 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
    Pco2 membranes for abl700 and abl800 can cause a negative bias on measurements on blood and qc. the bias can be seen after replacement of the membrane.

Device

ABL700
  • Model / Serial
    Model Catalog: 942-063 (Lot serial: N/A)
  • Product Description
    pCO2 membrane D788 used with ABL700 and ABL800 series analyzers
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS