Events

Alerte De Sécurité sur 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)

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.

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
    1870
  • Date
    2016-04-11
  • 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
    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.
  • Cause
    Abbott has confirmed that fulvestrant (faslodex®) may interfere with the architect estradiol assay, leading to falsely elevated estradiol results.
  • Action
    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

Device

ARCHITECT ESTRADIOL REAGENTS - Registration number ANVISA: 80146501210 - Classification of risk: ...

Manufacturer

Abbott Laboratórios do Brasil
  • 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