Events

Rappel de Reagent kit, calibrators and controls for the in vitro determination of highly sensitive troponin-I on immunochemical analyzers ARCHITECT i

Selon Federal Service for Surveillance in Healthcare, ce/cet/cette rappel concerne un dispositif en/au/aux/à Russian Federation qui a été fabriqué par Abbott Laboratories.

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
    01И-1760/16, РЗН 2014/1637
  • Date
    2016-09-08
  • Date de publication de l'événement
    2016-09-09
  • Pays de l'événement
    Russian Federation
  • Source de l'événement
    FSSH
  • URL de la source de l'événement
    http://www.roszdravnadzor.ru/services/unreg
  • Notes / Alertes
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 Russia.
  • Notes supplémentaires dans les données
    Manufacturer Recall

Device

Reagent kit, calibrators and controls for the in vitro determination of highly sensitive troponin...

Manufacturer

Abbott Laboratories
  • 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
    FSSH