Events

Rappel de Panbio Q Fever IgM ELISA (An in vitro diagnostic medical device (IVD))

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-01050-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-30
  • 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-01050-1
  • 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
    The manufacturer’s internal investigations of the lot number listed above have indicated kit degradation during stability monitoring, thus affecting the performance of the kit prior to kit expiry. one customer complaint has also been received relating to this issue. due to the instability of the serum used in manufacturing the positive control and calibrator, the values of positive control, calibrator and cut-off were out of specification. the fluctuating values could lead to a potential risk of false positive/false negative results.
  • Action
    Alere is requesting their customers to immediately discontinue use of this lot and dispose of any remaining affected product and is providing refund for the unused kits. Alere is recommending that a review of the previously reported results be undertaken. Alere is discontinuing this product and requesting the users to investigate an alternative method of testing Q fever. This action has been closed-out on 06/06/2016.

Device

Panbio Q Fever IgM ELISA (An in vitro diagnostic medical device (IVD))

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