Events

Recall of TRUETRACK BLOOD GLUCOSE MONITORING SYSTEM - BLOOD GLUCOSE METER

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
    115143
  • Event Risk Class
    I
  • Event Initiated Date
    2013-10-11
  • 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
    The company has determined that certain isolated truetrack blood glucose meter distributed in canada have an incorrect factory-set unit of measure. in canada the meter display the glucose result in mg/dl rather than mmol/l.

Device

TRUETRACK BLOOD GLUCOSE MONITORING SYSTEM - BLOOD GLUCOSE METER
  • Model / Serial
    Model Catalog: A4I20-81 (Lot serial: >100 numbers contact mfg)
  • Product Description
    Truetrack Blood Glucose Meter
  • Manufacturer
    TRIVIDIA HEALTH INC.

Manufacturer

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