Events

Rappel de i-STAT troponin I Assay Cartridges (cTnl). 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 Abbott Australasia Pty Ltd Point-of-Care Division.

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-2016-RN-00230-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-03-01
  • 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-2016-RN-00230-1
  • 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
    Abbott point of care (apoc) has determined that there is a possibility that a very small percentage of i-stat ctni cartridges distributed from the affected lot number may have a product identifier other than ctni embossed on the thumbwell of individual cartridges. the outside box and cartridge pouch were labelled correctly for these specified lots. the ctni cartridges from the affected lot can continue to be used for patient testing. the internal components, such as the reagent and analysis solution, are not impacted and the i-stat system will appropriately recognise the cartridge as ctni.
  • Action
    Abbott Point of Care is advising customers that a product replacement will be provided for any impacted stock.

Device

i-STAT troponin I Assay Cartridges (cTnl). An in vitro diagnostic medical device (IVD)

Manufacturer

Abbott Australasia Pty Ltd Point-of-Care Division
  • 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