Events

Rappel de Alere Determine HIV-1/2 Ag/Ab Combo (an in vitro diagnostic medical device)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Inverness Medical Innovations Australia Pty Ltd T/A Alere.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-01216-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01216-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    This action is being initiated as a result of alere’s post market surveillance activity. specifically, negative results were obtained from a single sample in the eqa ring trial in europe. this sample was taken from a 40 year old man with a 7 day history of fever, rash and fatigue and contained p24 antigen of a virus of subtype c at a concentration of 250 pg / ml (viral load of 2,500,000 copies / ml), corresponding to 50 iu / ml (who standard). a recent publication of a survey conducted in swaziland also suggested that the antigen component of the alere determine hiv-1/2 ag/ab combo test in a high-prevalence, high-incidence setting was unable to detect acute infection in this subtype c population.
  • Action
    Alere is notifying hospitals of the following additional assay limitations: - The test is designed to provide an additional, rapid testing option for the detection of HIV infections. The sensitivity of the Alere Determine HIV-1/2 Ag/Ab Combo is not equivalent to 4th generation HIV ELISA, p24 EIA or PCR, which limits its ability to detect acute infections in comparison to those methods. - Where clinical presentation or other data would suggest an inconsistent result then the patient should be tested by PCR and/or retested for antibodies to HIV >21 days after the original testing. This action has been closed-out on 18/03/2016.

Device

Alere Determine HIV-1/2 Ag/Ab Combo (an in vitro diagnostic medical device)

Manufacturer

Inverness Medical Innovations Australia Pty Ltd T/A Alere
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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