Events

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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL LTDA; Abbott GmbH & Co. KG..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1534
  • Fecha
    2015-02-25
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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%.
  • Acción
    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.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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