Events

Recall of TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitoring System). An in vitro diagnostic medical device (IVD)

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-2016-RN-00632-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00632-1
  • 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
    This recall has been initiated as a limited number of sealed test strip vial boxes from the affected trueresult blood glucose test strip batch may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can adversely affect the strips performance. in particular, test strips exposed to the environment may provide falsely low blood glucose results. falsely low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment.Action based on falsely low results may raise blood glucose levels further, resulting in potentiated hyperglycemia which may require medical intervention.
  • Action
    Nipro is advising users to inspect stock and quarantine any remaining stocks of the affected batch for return. This action has been closed-out on 03/02/2017.

Device

TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitorin...
  • Model / Serial
    TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitoring System). An in vitro diagnostic medical device (IVD) Item Number: E4i08-81FDExpiry Date: 25/06/2018Batch Number: KS1741ARTG Number: 180121
  • Manufacturer
    Nipro Australia Pty Ltd

Manufacturer

Nipro Australia Pty Ltd