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
    64219
  • Event Risk Class
    II
  • Event Initiated Date
    2007-07-19
  • 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
    Internal testing has shown that when running an average of more than 70 samples per day a bias of sodium of more than 2mmol/l may occur.

Device

ABL700
  • Model / Serial
    Model Catalog: S7770 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 962-169 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: S5362 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: S4970 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: S1730 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: S1720 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: RADIANCE (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 962-170 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 393-825 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 393-726 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 393-725 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 393-721 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 393-720 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 393-706 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 393-705 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 393-701 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 393-700 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: S7370 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    D711 REFERENCE MEMBRANE ABL7XX
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS