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
    103565
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-12
  • 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 rapporte que des resultats de microbiologie etaient absents sur des rapports de resultats publies par un systeme tiers de telecopie. ce client est le seul a utiliser l'interface de resultats sortants en format xml d'omnitech labs pour alimenter un systeme de telecopie et le seul a utiliser la version concernee. le probleme est lie a la presence de plusieurs antibiogrammes identiques commandes et valides pour une meme identification (c.-a-d. une meme gelose ou un meme microorganisme) et pour lesquels les resultats qui ne sont pas les plus recents auraient du etre annules par le technicien de laboratoire conformement a la methodologie de travail de laboratoire habituelle.

Device

INTERFACE DE RESULTATS SORTANTS XML
  • Model / Serial
    Model Catalog: VERSION 2.0.0.15 (Lot serial: Version 2.0.0.15)
  • 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