Events

Rappel de Alinity i system

Selon Pharmaceuticals and Medical Devices Agency, Japan, ce/cet/cette rappel concerne un dispositif en/au/aux/à Japan qui a été fabriqué par Abbott Japan 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
    2-7672
  • Date
    2017-10-18
  • Pays de l'événement
    Japan
  • Source de l'événement
    PMDAJ
  • URL de la source de l'événement
    http://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-7672
  • Notes / Alertes
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, 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 Japan.
  • Notes supplémentaires dans les données
    2017/11/24 "2. Correction of target lot, quantity and shipping time" Collection end

Device

Alinity i system
  • Modèle / numéro de série
  • Description du dispositif
    Immunofluorescence measuring device
  • Manufacturer
    Abbott Japan Co., Ltd.

Manufacturer

Abbott Japan 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
    PMDAJ