Alerta De Seguridad para Slidex Menigite Kit - 5 Reference: 58803 - Lots: 804625001, effective 01.02.2007 and 805849801, validity 03.03.2007

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomérieux França.

¿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
    850
  • Fecha
    2006-12-27
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    According to the Company's information the latex reagents of the batches described are within the specifications of use, as a preventive measure, they decided to interrupt the use, promoting the collection. Check if there are such batches in your inventory, if any, fill out the collection form and send to BIOMÉRIEUX BRASIL S / A via fax (xx) 21 - 2445 95 23, in order to make the return and consequently the replacement of the lots involved . The UTVIG - Technovigilance Unit is monitoring the entire collection and replenishment process until it closes. Letter dated 16.03.2007 from the Company informing the closing of the payment.
  • Causa
    Lot: 804625001 - risk of decreased sensitivity over the time of reagent r 5 (latex n. meningitidis type c), compared to reagent r ¨ (positive control), due to one of the raw materials used. biomérieux brasil s / a clarifies that despite the mentioned problem, reagent r 5 remains within specifications. r 6 (positive control) with reagent r 4 (n. meningitidis group b).
  • Acción
    Voluntary collection.

Manufacturer

  • Source
    ANVSANVISA