Events

Alerta De Seguridad para DIAGNOSTIC REAGENTS FOR USE IN VITRO VIDAS CHLAMYDIA / REF. 30101 ANVISA Registry No. 10158120169 - LOTS: 040212-0 E 040218-0

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

¿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
    732
  • Fecha
    2003-08-26
  • 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
    The company informs that a credit will be generated to the Laboratories, and that it has already begun the import process in emergency catater, once all the stock has been totally compromised due to the collection. If you received a letter dated August 26, 2003, complete the Return Certificate and return it by fax 21-2445.9523. For further information, please contact BIOMÉRIEUX BRASIL SA, by calling 0800 26 4848 - option 2, or your local representative.
  • Causa
    The process of decreasing the stability of a raw material that composes the reagents was detected, this fact could generate false negative results.
  • Acción
    Issue of letter dated August 26, 2003 - Notice of Collection - requesting to suspend the use of lots and to retest all samples of negative results since July 24.

Device

DIAGNOSTIC REAGENTS FOR USE IN VITRO VIDAS CHLAMYDIA / REF. 30101 ANVISA Registry No. 10158120169...

Manufacturer

BIOMÉRIEUX BRASIL S.A
  • Source
    ANVSANVISA