Events

Rappel de SD BIOLINE HIV Ag/Ab Combo, SD03FK30

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
    21340
  • Date de mise en oeuvre de l'événement
    2017-04-20
  • 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
    The manufacturer received complaints and confirmed that certain lots did not meet the performance claim for analytical sensitivity of p24 antigen (the claimed detection limit in the package insert is 2 iu/ml, however the lots listed detect a concentration of 16 iu/ml.).
  • Action
    Product to be destroyed

Device

SD BIOLINE HIV Ag/Ab Combo, SD03FK30
  • Modèle / numéro de série
    Model: , Affected: Lot numbers, 03BDA005A, 03BDA006A, 03BDA006B, 03BDB001C
  • 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