Events

Recall of ABL800 FLEX SYSTEM - INSTRUMENT CONFIGURATIONS

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
    23605
  • Event Risk Class
    II
  • Event Initiated Date
    2006-11-09
  • 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
    When the protein removal program is run too frequently on analyzers with software version 5.24 the reference membrane may become damaged and result in incorrect ph and electrolyte values being reported.

Device

ABL800 FLEX SYSTEM - INSTRUMENT CONFIGURATIONS
  • Model / Serial
    Model Catalog: 393-820 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 393-817 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 393-816 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 393-806 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 393-805 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 393-804 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 393-803 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 393-801 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 393-800 (Lot serial: CONTACT MANUFACTURER); Model Catalog: 393-845 (Lot serial: >10 NUMBERS); Model Catalog: 393-844 (Lot serial: >10 NUMBERS); Model Catalog: 393-836 (Lot serial: >10 NUMBERS); Model Catalog: 393-835 (Lot serial: >10 NUMBERS); Model Catalog: 393-828 (Lot serial: >10 NUMBERS); Model Catalog: 393-827 (Lot serial: >10 NUMBERS); Model Catalog: 393-826 (Lot serial: >10 NUMBERS); Model Catalog: 393-825 (Lot serial: >10 NUMBERS); Model Catalog: 393-821 (Lot serial: >10 NUMBERS); Model Catalog: 393-820 (Lot serial: >10 NU
  • Product Description
    ABL800 FLEX SYSTEM
  • Manufacturer
    RADIOMETER CANADA

Manufacturer

RADIOMETER CANADA
  • Manufacturer Address
    LONDON
  • Source
    HC