Events

Recall of TDHISTO/CYTO

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SERVICES TECHNIDATA CANADA 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
    133635
  • Event Risk Class
    II
  • Event Initiated Date
    2013-12-10
  • 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
    Dans les versions v11.71.A du logiciel tdhisto/cyto ainsi que dans les versions superieures il existe un risque de passer accidentellement une demande d'examens en statut "valide" suite a un enchainement precis d'ecrans (voir la communication faite aux utilisateurs pour plus de detail). ce phenomene peut conduire a diffuser un resultat patient qui n'a pas ete valide cliniquement. ce defaut ne concerne que les sites utilisant le mode de validation "ecran".^.

Device

TDHISTO/CYTO
  • Model / Serial
    Model Catalog: TD-TDH-01 (Lot serial: V. V11.71.A ET SUPERIEURES)
  • Product Description
    TDHISTO/CYTO
  • Manufacturer
    SERVICES TECHNIDATA CANADA INC.

Manufacturer

SERVICES TECHNIDATA CANADA INC.
  • Manufacturer Address
    MONTREAL
  • Source
    HC