Events

Recall of Alere HIV Combo. 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-2017-RN-00856-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00856-1
  • 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
    Internal investigations by alere have identified that when testing with edta whole blood samples, specific lots of alere hiv combo may exhibit increased frequency of a red bar in the antigen (p24) result window, which could be interpreted as a false positive result. these bars may be faint. antigen (p24) performance with other sample types continues to perform as per product specifications. performance for hiv-1 and hiv-2 antibody is as per product specifications.
  • Action
    Alere is requesting customers: 1. If you have forwarded affected product to another location, provide a copy of this letter to them; 2. Review the instructions for use of the assay (and any other algorithm requirements applicable to your facility). Ensure that the requirement for retesting of initially reactive specimens is understood; 3. Ensure that initially reactive p24 antigen and/or antibody results are retested using another method and the results are evaluated in consideration of the overall clinical evaluation before a diagnosis is made; and 4. Retain the notification as part of your records. fax or e-mail Customer Verification form to Alere Technical Support: Fax Number 07 3363 7199 or au.techsupport@alere.com

Device

Alere HIV Combo. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Alere HIV Combo. An in vitro diagnostic medical device (IVD)Catalogue Number: 7D2846Lot Number: 80671K100CPack Size: 20 TestsCatalogue Number: 7D2847Lot Number: 78169K100BPack Size: 100 TestsARTG Number: 276049
  • 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