Alerta De Seguridad para ARCHITECT ESTRADIOL REAGENTS - Registration number ANVISA: 80146501210 - Classification of risk: II - Lots Affected: 55900UI01, 55908UI01, 55941UI00, 57929UI00, 57931UI01, 60105UI00, 55900UI00, 55908UI00, 57929UI01, 57931UI00 and 60105UI01 (MAP OF DISTRIBUTION IN ATTACHMENT)

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.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The potential health risk applies only to patients receiving Fulvestrant, which may lead to elevated estradiol levels. In the worst case scenario, falsely elevated estradiol results may lead to an incorrect assessment of the menopausal status and inadequate treatment. Tests performed as a research study showed the following results as shown below: Population that the estradiol concentration represents: Postmenopausal women Outcome of estradiol in the sample without dilution pg / mL (pmol / L): 29.14 * (106, 94) Estradiol result in the supplemented sample pg / mL (pmol / L): 85.80 (314.89)% Recovery (Interference): 294.44% Cross Reactivity: 0.23 - A sample was supplemented with 25,100 pg / Fulvestrant (25.100 pg / mL is a representative maximum concentration of Fulvestrant) -% Recovery = (result of the supplemented sample / result of the sample without dilution) X 100. -% Cross Reactivity = ((result of sample supplemented in pg / mL - result of sample without dilution in pg / mL) / Fulvestrant concentration supplemented in pg / mL) X 100. * Sample of human serum not supplemented.
  • Causa
    Abbott has confirmed that fulvestrant (faslodex®) may interfere with the architect estradiol assay, leading to falsely elevated estradiol results.
  • Acción
    Company is directing its clients to "Do not use Estradiol test for specific group", according to LETTER TO THE CLIENTS IN ANNEX. Here are the recommendations of the company: (1). Review this statement together with your Medical Officer (FORM IN ANNEX); (2). Patients receiving Fulvestrant should not be tested with the ARCHITECT Estradiol assay; (3). Fill out the Customer Response Form (template in ANNEX); (4). If you have forwarded the above product to other laboratories, please inform them of the Product Correction and provide a copy of this notice; (5). Keep a copy of this statement in your lab files. ## Code FA24MAR2016A


  • Empresa matriz del fabricante (2017)
  • 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