Events

Recall of TRUE TRACK SMART SYSTEM - BLOOD GLUCOSE TEST STRIPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TRIVIDIA HEALTH 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
    35731
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-28
  • 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
    A limited number of sealed test strip vial boxes from certain blood glucose test strip lots may include an open test strip vial. test strips contained within open vials are exposed to the outside environment which can affect strip performance. in particular test strips exposed to the environment may provide incorrect low blood glucose results. inaccurate low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment.

Device

TRUE TRACK SMART SYSTEM - BLOOD GLUCOSE TEST STRIPS
  • Model / Serial
    Model Catalog: A3I20-81 (Lot serial: Lot#: RS4704ICA); Model Catalog: A3I20-80 (Lot serial: Lot#: RS4704ICA); Model Catalog: A3I20-81 (Lot serial: Lot#: RS4567ICA); Model Catalog: A3I20-80 (Lot serial: Lot#: RS4567ICA); Model Catalog: E3I20-81 (Lot serial: Lot#: PS2335ICA); Model Catalog: E3I20-80 (Lot serial: Lot#: PS2335ICA); Model Catalog: E3I20-81 (Lot serial: Lot#: PS2316ICA); Model Catalog: E3I20-80 (Lot serial: Lot#: PS2316ICA); Model Catalog: E3I20-81 (Lot serial: Lot#: PS2284ICA); Model Catalog: E3I20-80 (Lot serial: Lot#: PS2284ICA)
  • Product Description
    TRUEtrack Blood Glucose Test Strips;TRUEtest Blood Glucose Test Strips
  • Manufacturer
    TRIVIDIA HEALTH INC.

Manufacturer

TRIVIDIA HEALTH INC.
  • Manufacturer Address
    FORT LAUDERDALE
  • Manufacturer Parent Company (2017)
    Sinocare Inc.
  • Source
    HC