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
    21523
  • Event Risk Class
    II
  • Event Initiated Date
    2017-02-15
  • 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
    En cours d'investigation d'un probleme rapporte par un client l'equipe d'omnitech labs a decouvert qu'une combinaison de configurations empeche les cas de microbiologie dont le statut est "amande preliminaire" ou "commentaire preliminaire" de se retrouver dans les listes de cas en attente de traitement. en resume le probleme touche les clients dont le systeme est configure pour l'utilisation de la validation par un microbiologiste et du bouton "confirmation" qui se trouve sous l'onglet "identification".

Device

OMNILAB V.12.0 - LABORATORY INFORMATION SYSTEM
  • Model / Serial
    Model Catalog: VERSION 12.10.0.148 (Lot serial: Version 12.10.0.148); Model Catalog: VERSION 12.12.0.130 (Lot serial: Version 12.10.0.148); Model Catalog: VERSION 12.10.0.116 (Lot serial: Version 12.10.0.148); Model Catalog: VERSION 12.10.0.148 (Lot serial: Version 12.12.0.130); Model Catalog: VERSION 12.10.0.116 (Lot serial: Version 12.10.0.116); Model Catalog: VERSION 12.10.0.116 (Lot serial: Version 12.12.0.130); Model Catalog: VERSION 12.10.0.148 (Lot serial: Version 12.10.0.116); Model Catalog: VERSION 12.12.0.130 (Lot serial: Version 12.10.0.116); Model Catalog: VERSION 12.12.0.130 (Lot serial: Version 12.12.0.130)
  • 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