Events

Recall of ABL80 FLEX SYSTEM - ANALYZER

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
    25017
  • Event Risk Class
    II
  • Event Initiated Date
    2007-04-16
  • 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
    There have been reports that waste fluid has sprayed out from the waste drain at the front of the abl80 analyzer. this occurs when excessive pressure builds within the waste line due to a blockage in the line.

Device

ABL80 FLEX SYSTEM - ANALYZER
  • Model / Serial
    Model Catalog: 393-839 (Lot serial: L300396 L300452 L300391); Model Catalog: 393-839 (Lot serial: L300107 L300379 L300502); Model Catalog: 393-839 (Lot serial: L300389 L300390 L300378); Model Catalog: 393-839 (Lot serial: L300482 L300110 L300319); Model Catalog: 393-839 (Lot serial: L300500 L300154 L300263); Model Catalog: 393-839 (Lot serial: L300167 L300376)
  • Product Description
    ABL80 FLEX ANALYZER
  • Manufacturer
    RADIOMETER CANADA

Manufacturer

RADIOMETER CANADA
  • Manufacturer Address
    LONDON
  • Source
    HC