Events

Recall of FreeStyle Papillon Mini Blood Glucose Monitoring System

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-2014-RN-00167-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00167-1
  • 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
    Abbott diabetes care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or give blood glucose results which could affect clinical outcome or have significant medical risk when used in conjunction with any freestyle test strip lot within expiry.Br /br /this is an update to the recall initiated in november 2013 on certain lots of freestyle blood glucose test strips (rc-2013-rn-01228-1). the freestyle papillion mini blood glucose monitoring system has not been supplied in australia since 2009.Br /br /further inforamtion on this recall can be found at http://www.Tga.Gov.Au/safety/alerts-device-freestyle-strips-papillon-mini-140304.Htm.
  • Action
    Abbott is providing consumers who are still the possession of of a FreeStyle Papillion Mini blood glucose meter with a replacement FreeStyle branded meter.

Device

FreeStyle Papillon Mini Blood Glucose Monitoring System

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