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
    89804
  • Event Risk Class
    III
  • Event Initiated Date
    2015-03-13
  • 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 rapport d'un patient n'a pas ete transmis a son interface de resultats sortants qui alimente le dossier de sante du quebec (dsq). ceci touche egalement les interfaces sous-jacentes qui sont alimentees par la meme source de donees. la publication electronique du rapport de ce patient n'a donc pas ete acheminee au moteur de l'interface. ceci concerne des requetes qui comprennent des listes de tests (panels) dont certains resultats de tests sont absents.

Device

  • Model / Serial
    Model Catalog: SETUPCHANGESET_2848 (Lot serial: Version 1.0.0.6)
  • Product Description
    INTERFACE DE RESULTATS SORTANTS XML
  • Manufacturer

Manufacturer

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