Events

Recall of STAT PROFILE M1 ANALYZER - SENSORS

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

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
    49558
  • Event Risk Class
    II
  • Event Initiated Date
    2003-10-14
  • 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
    Ionized magnesium sensors greater than 5 months old from the manufacturing date demonstrate degradation of performance of the sensor which is not identified by the use of quality control materials.

Device

STAT PROFILE M1 ANALYZER - SENSORS
  • Model / Serial
    Model Catalog: 20394 (Lot serial: )
  • Product Description
    STAT PROFILE M MG++ SENSOR
  • Manufacturer
    NOVA BIOMEDICAL CORPORATION

Manufacturer

NOVA BIOMEDICAL CORPORATION