Events

Recall of SYNCHRON EL-ISE ANALYZERS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER 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
    20923
  • Event Risk Class
    II
  • Event Initiated Date
    2005-05-19
  • 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
    Potassium electrodes may not meet its six month performance life and/or show higher than expected results during calibration period.

Device

SYNCHRON EL-ISE ANALYZERS
  • Model / Serial
    Model Catalog: 75UJM (Lot serial: LOT 446-508)
  • Product Description
    SYNCHRON EL-ISE POTASSIUM ELECTRODE TIP
  • Manufacturer
    BECKMAN COULTER INC.

Manufacturer

BECKMAN COULTER INC.