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
    19758
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-07
  • 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
    In the main "order entry" screen and in the "analyzing" screen of the core lab module users can delete the priority for a test and leave the field empty or press the spacebar to only insert a blank space.

Device

OMNILAB V.12.0 - LABORATORY INFORMATION SYSTEM
  • Model / Serial
    Model Catalog: N/A (Lot serial: >10 contact mfr)
  • Product Description
    OMNILAB V.12
  • Manufacturer
    OMNITECH LABS INC.

Manufacturer

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