Events

Recall of ABL 70 SERIES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RADIOMETER CANADA.

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
    94457
  • Event Risk Class
    II
  • Event Initiated Date
    2005-10-04
  • 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
    An elevated po2 measurement observed when running a level 2 and 3 quality controls on an abl77 analyzer utilizing a calpack from identified lot number.

Device

ABL 70 SERIES
  • Model / Serial
    Model Catalog: 944-069 (Lot serial: 9946)
  • Product Description
    CALPACK FOR ABL77 BLOOD GAS SYSTEM
  • Manufacturer
    RADIOMETER CANADA

Manufacturer

RADIOMETER CANADA
  • Manufacturer Address
    LONDON
  • Source
    HC