Events

Rappel de INNOVACON STREP A RAPID TEST DEVICE (THROAT SWAB)

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ALERE CANADA.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    35615
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-10-05
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Through testing it was determined that this product may have an elevated incidence of false positive results. a false positive test result could lead to the administration of antibiotics that are unnecessary. this exposes the patient to potential side effects or allergic reactions. these are rarely serious and are usually resolved with discontinuation of the medication. as with all diagnostic tests all results must be interpreted together with other clinical information available to the physician. it is unnecessary to interrupt a course of antibiotics that have little to no negative side effects.

Device

INNOVACON STREP A RAPID TEST DEVICE (THROAT SWAB)
  • Modèle / numéro de série
    Model Catalog: IST-502 (Lot serial: All)
  • Description du dispositif
    INNOVACON STREP A RAPID TEST DEVICE (THROAT SWAB)
  • Manufacturer
    ALERE CANADA

Manufacturer

ALERE CANADA
  • Adresse du fabricant
    OTTAWA
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC