Events

Alerta De Seguridad para Commercial Name: VITROS IMUNODIAGNOSTIC REAGENT KIT * ECi FOR TOTAL T4 //////// ANVISA Registration No. 10132590400 //////// Risk Class II ////// Lots Affected and Imported in Brazil: 1845, 1880, 1900, 1930, 1950

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS.

¿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
    1944
  • Fecha
    2016-07-11
  • 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
    If you have any questions regarding this field action, please contact Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. by telephone: 12 3932-7977 or e-mail: gbuosi@its.jnj.com
  • Causa
    Tests indicated that the sample results, generated using the vitros tt4 reagent kits that were open more than 4 weeks ago, may demonstrate a negative bias. incorrect value may cause undue results. the laboratory medical officer should be consulted about any questions you may have regarding previously reported tt4 results to determine the appropriate course of action. the results of this or other diagnostic test should be used and interpreted only within the context of the general clinical picture.
  • Acción
    Action code 16000094. Sending of Letter to the Clients // Update of Instruction of Use.

Device

Commercial Name: VITROS IMUNODIAGNOSTIC REAGENT KIT * ECi FOR TOTAL T4 //////// ANVISA Registrati...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS