Events

Alerte De Sécurité sur Architect diagnostic kit ANTI-HBc II reagents; Brand: Abbott, Registration: 80146501602, Serial numbers: 42072LI00, 42072LI01, 42253LI00 and 42253LI01.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ABBOTT LABORATÓRIOS DO BRASIL LTDA; Abbott GmbH & Co. KG..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1534
  • Date
    2015-02-25
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to company information there is potential for occurrence of false-positive results. There is no impact on the sensitivity of the assay and the risk is associated with misunderstanding that a patient is infected with the HBV virus and performing additional tests.
  • Cause
    Reduction of specificity to 99.2% and increase of the false-positive result in the tests carried out in the architect anti-hbc ii kit. the specificity value is below the specifications found in the instructions for use which is 99.5%.
  • Action
    The company asks customers to discontinue use of the affected lots, complete the customer response form, and disclose information about the problem in the diagnostic kits and any additional tests that may be performed.

Device

Architect diagnostic kit ANTI-HBc II reagents; Brand: Abbott, Registration: 80146501602, Serial n...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA; Abbott GmbH & Co. KG.
  • 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
    ANVSANVISA