Events

Recall of One Touch Verio IQ Blood Glucose Monitoring System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-00243-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00243-1
  • 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
    At extremely high blood glucose levels of 56.8 mmol/l and above, the onetouch verio iq meter will turn off instead of displaying the message "extreme high glucose above 33.3 mmol/l" as intended. on restart the meter will enter set up mode.
  • Action
    Patients are advised to continue using their OneTouch Verio IQ meter until the replacement meter arrives. However, if the meter unexpectedly turns off and enters set-up mode after turning it back on, the patient should contact their Diabetes Nurse Educator or Health Professional as this may be an indication of extremely high blood glucose. Distributors and health services are being advised to immediately return all affected product.

Device

One Touch Verio IQ Blood Glucose Monitoring System

Manufacturer

Johnson & Johnson Medical Pty Ltd