Events

Recall of OMNILAB V.12.0 - LABORATORY INFORMATION SYSTEM

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
    21037
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-18
  • 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
    Lorsqu'omni-lab publie un rapport par telecopieur si le systeme de telecopie (telecopieur ou logiciel de tierce partie) n'est pas disponible ou ne repond pas omni-lab generera un code d'erreur ("pcl") apres l'echec de plusieurs tentatives. le rapport devra ensuite etre republie par un utilisateur a l'aide de l'option de publication d'omni-lab ou publie manuellement par l'equipe d'omnitech labs.

Device

OMNILAB V.12.0 - LABORATORY INFORMATION SYSTEM
  • Model / Serial
    Model Catalog: NA (Lot serial: NA)
  • Product Description
    OMNILAB V.12.0 - LABORATORY INFORMATION SYSTEM
  • Manufacturer
    OMNITECH LABS INC.

Manufacturer

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