Events

Recall of ABL800 FLEX SYSTEM - CA ELECTRODE AND MEMBRANE

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

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
    22036
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-12
  • 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
    Quality issue on ca++ menbrane unit 942-046 and 942-060. wrinles might arise on the outer membrane upon installation. retention of fluids between the wrinkles can cause a positive bias of up to 15% when measuring on whole blood at a level of approx. 080 mmol/l.

Device

ABL800 FLEX SYSTEM - CA ELECTRODE AND MEMBRANE
  • Model / Serial
    Model Catalog: 942-060 (Lot serial: ALL LOTS SINCE SEPT. 2010)
  • Product Description
    CA++ MEMBRANE CODE 942-060 AND 942-046
  • Manufacturer
    RADIOMETER AMERICA INC.

Manufacturer

RADIOMETER AMERICA INC.