Events

Recall of FreeStyle Lite Blood Glucose Test Strips (used with FreeStyle Papillon Mini Blood Glucose Meters). 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 Abbott Australasia Pty Ltd T/A Abbott Diabetes Care.

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-01228-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01228-1
  • 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
    The affected freestyle lite blood glucose test strips may produce erroneously low blood glucose results and out of range control solution results when used with the freestyle papillon mini blood glucose meters.Blood glucose results are not affected if using the freestyle lite blood glucose monitoring system, freestyle insulinx, blood glucose monitoring system or freestyle freedom lite blood glucose monitoring system.
  • Action
    Consumers are requested to contact Abbott Diabetes Care immediately to organise replacement of the affected test strips. If no alternative test method is available customers should continue to use the affected lots and contact their healthcare professionals in the event of a reading that appears lower than expected. For further information, please see http://www.tga.gov.au/safety/alerts-device-freestyle-lite-blood-glucose-test-strips-131122.htm

Device

FreeStyle Lite Blood Glucose Test Strips (used with FreeStyle Papillon Mini Blood Glucose Meters)...
  • Model / Serial
    FreeStyle Lite Blood Glucose Test Strips (used with FreeStyle Papillon Mini Blood Glucose Meters). An in vitro diagnostic medical device (IVD)Product Number: 70984.70Lot Numbers: 1366540, 1366621
  • Manufacturer
    Abbott Australasia Pty Ltd T/A Abbott Diabetes Care

Manufacturer

Abbott Australasia Pty Ltd T/A Abbott Diabetes Care
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA