Events

Recall of IMMULITE 2000 SYSTEM - CEA ASSAY

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

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
    15652
  • Event Risk Class
    III
  • Event Initiated Date
    2008-03-19
  • 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
    An adverse trend in stability may result in a significant decrease in the adjustment slopes (down to 0.7) and a negative shift in patient values of 20-25% at concentrations > approx. 300 ng/ml.

Device

IMMULITE 2000 SYSTEM - CEA ASSAY
  • Model / Serial
    Model Catalog: L2KCE6 (Lot serial: LOT 232)
  • Product Description
    IMMULITE 2000 CEA
  • Manufacturer
    INTER MEDICO

Manufacturer

INTER MEDICO
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Inter Medico
  • Source
    HC