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
    20928
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-18
  • 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
    Le resultat d'une recherche de parasites peut se transferer sur une requete de microbiologie au niveau de la culture. c'est-a-dire que si un utilisateur selectionne un resultat de culture pour une requete de parasitologie dans l'onglet "identification" et qu'il clique ensuite dans le champ "no. de requete" de l'onglet de base de l'ecran principal du module de microbiologie puis qu'il entre un numero de requete de microbiologie (ou scanne une etiquette de requete a l'aide d'un lecteur code-barres) le resultat de la requete de parasitologie present a l'ecran se retrouve dans la requete de microbiologie appelee a l'ecran. le resultat de la requete de microbiologie est remplace par un resultat de parasitologie.

Device

OMNILAB V.12.0 - LABORATORY INFORMATION SYSTEM
  • Model / Serial
    Model Catalog: N/A (Lot serial: Version 12.10.0.130); Model Catalog: N/A (Lot serial: Version 12.10.0.129)
  • Product Description
    OMNI-Lab -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