Events

Recall of TREMBLAY HARRISON MINUTE LAB STREP A RAPID TEST DEVICE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by WHOLESALE MEDICAL NETWORK 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
    38601
  • Event Risk Class
    II
  • Event Initiated Date
    2012-10-09
  • 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
    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
  • Model / Serial
    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)
  • Product Description
    Tremblay Harrison Minute Lab Strep A Rapid Test
  • Manufacturer
    WHOLESALE MEDICAL NETWORK INC.

Manufacturer

WHOLESALE MEDICAL NETWORK INC.
  • Manufacturer Address
    TORONTO
  • Source
    HC