Events

Rappel de Alere HIV Combo

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Alere Medical Co Ltd.

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
    21676
  • Date de mise en oeuvre de l'événement
    2017-07-11
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Alere Ltd, C/- Bell Gully, Level 22, Vero Centre, 48 Shortland Street, AUCKLAND 1010
  • Cause
    Internal investigations have identified that when testing with edta whole blood samples, 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
    Manufacturer to issue advice regarding use

Device

Alere HIV Combo
  • Modèle / numéro de série
    Model: , Affected: 20 Tests Kits catalogue number 7D2846, Lot number 80671K100C
  • Manufacturer
    Alere Medical Co Ltd

Manufacturer

Alere Medical Co Ltd
  • 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
    NZMMDSA