Events

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
    97714
  • Event Risk Class
    III
  • Event Initiated Date
    2015-05-06
  • 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
    Un client a signale que ses tableaux d'interpretation de resultats n'etaient pas transmis via son interface avec le dsq (dossier de sante du quebec). les rapports patients sont publies avec les tableaux d'interpretation dans le syslteme omni-lab cependant dans l'extraction de donnees en format xml qui alimente le dossier dsq et les interfaces qui s'alimentent a meme ce ficher xml ces requetes ont potentiellement ete acheminees a l'engin d'interface sans les tableaux d'interpretation. la composante "getbio testshierarchy" revision 3 et 4 est concernee.

Device

INTERFACE DE RESULTATS SORTANTS XML
  • Model / Serial
    Model Catalog: VERSION 1.0.0.7 (Lot serial: Version 1.0.0.7)
  • Product Description
    INTERFACE DE RESULTATS SORTANTS XML
  • Manufacturer
    OMNITECH LABS INC.

Manufacturer

OMNITECH LABS INC.
  • Manufacturer Address
    SAINT-JEAN-SUR-RICHELIEU
  • Manufacturer Parent Company (2017)
    Omnitech Labs Inc
  • Source
    HC