Events

Recall of TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Nipro Australia Pty Ltd.

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
    RC-2013-RN-01079-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01079-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    As part of nipro diagnostics internal manufacturing process blood glucose meters are required to be reconfigured to meet country specific requirements. during the reconfiguration process, the unit of measure was set incorrectly on a small subset of truebalance and truetrack meters supplied in australia. specifically, a miscalibrated meter would use mg/dl instead of mmol/l, which is the standard unit used in australia.This recall was initiated by nipro australia prior to consulting with the tga.
  • Action
    Nipro is advising users to check the serial number on the back of the meter to identify if their meter is affected. An alternative method for measuring blood glucose levels should be used if you have an affected meter. Affected meters can be returned to Nipro for a replacement unit. For more details, please see http://tga.gov.au/safety/alerts-device-nipro-glucose-meter-131031.htm .

Device

TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems

Manufacturer

Nipro Australia Pty Ltd