Events

Recall of epoc BGEM Test Card (blood gas, electrolyte and metabolite test card panel), 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 Inverness Medical Innovations Australia Pty Ltd T/A Alere.

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-00289-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00289-1
  • 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 manufacturer has determined that the referenced lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end range of glucose test sensor. specifically, in test cards aged to within 2.5 months (75 days) of their expiration date, a negative bias between of 15 – 30 % has been observed in sample with glucose levels greater than 22 mmol/l. all glucose measurements between the low end of the reportable range and 22 mmol/l are accurately reported, as are all other assay results in the affected cards.
  • Action
    Alere is instructing end users to discontinue the use of, and to destroy, any remaining affected units. Unaffected kits will be provided to customers by Alere to replace the recalled units.

Device

epoc BGEM Test Card (blood gas, electrolyte and metabolite test card panel), An in vitro diagnost...
  • Model / Serial
    epoc BGEM Test Card (blood gas, electrolyte and metabolite test card panel), An in vitro diagnostic medical device (IVD).Catalogue Number: CT-1004-00-00Lot Numbers: 07-12289-00 & 07-01263-00ARTG Number: 198588
  • Manufacturer
    Inverness Medical Innovations Australia Pty Ltd T/A Alere

Manufacturer

Inverness Medical Innovations Australia Pty Ltd T/A Alere
  • 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