Events

Rappel de TREMBLAY HARRISON MINUTE LAB STREP A RAPID TEST DEVICE

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

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
    38601
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-10-09
  • 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
    Tremblay harrison is a private label manufacturer of the stw-a1. we were notified on september 182011 by the manufacturer innovacon inc. that they are undertaking a voluntary recall of the tests as they have discovered an elevated incidence of false positive results. a false positive result could lead to the administration of antibiotics that are unnecessary. this exposes the patient to potential side effects or allergic reaction. these are rarely serious and are usually resolved with discontinuation of medication. as with all diagnostic tests all results must interpreted together with other clinical information available to the physician. the health hazard evaluation has concluded that the overall health risk is low.

Device

TREMBLAY HARRISON MINUTE LAB STREP A RAPID TEST DEVICE
  • Modèle / numéro de série
    Model Catalog: STW-A1 (Lot serial: STA0110106); Model Catalog: STW-A1 (Lot serial: STA0110011); Model Catalog: STW-A1 (Lot serial: STA0010072); Model Catalog: STW-A1 (Lot serial: STA0100087)
  • Description du dispositif
    Tremblay Harrison Minute Lab Strep A Rapid Test
  • Manufacturer
    WHOLESALE MEDICAL NETWORK INC.

Manufacturer

WHOLESALE MEDICAL NETWORK INC.
  • Adresse du fabricant
    TORONTO
  • Source
    HC