Recall of INTERFACE DE RESULTATS SORTANTS XML

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OMNITECH LABS 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
    87654
  • Event Risk Class
    III
  • Event Initiated Date
    2014-08-27
  • Event Country
  • 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
    Un client nous a signale un rapport qui n'a pas ete transmis a son interface de resultats sortants vers un dossier medical electronique (dme). ce rapport patient aurait du etre transmis via une extraction de donnees en format xml qui alimente le dossier de sante du quebec (dsq) et les interfaces sous-jacentes qui s'alimentent a meme le fichier xml. la publication electronique des donnees de cette requete n'a potentiellement pas ete acheminee a l'engin d'interface.

Device

  • Model / Serial
    Model Catalog: SETUPCHANGESET_2848 (Lot serial: N/A)
  • Product Description
    INTERFACE DE RESULTATS SORTANTS XML
  • Manufacturer

Manufacturer

  • Manufacturer Address
    SAINT-JEAN-SUR-RICHELIEU
  • Manufacturer Parent Company (2017)
  • Source
    HC