Events

Alerta De Seguridad para AXSYM AFP REAGENTS - Reg. No. 10055310293, list no. 7A48-22

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 LTDA.

¿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
    735
  • Fecha
    2003-07-22
  • 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
    Check if you received communication from 16.07.2003 of ABBOTT LABORATORIES DO BRASIL LTDA, if you have not received contact ABBOTT LABORATORIES DO BRASIL LTDA, by telephone 11 5367000 or your local representative.
  • Causa
    Elevation of afp values ​​by up to 30.5% when compared to manual dilution. these abnormalities are seen only in samples of amniotic fluid and serum samples, which are high enough to require a 1: 101 dilution (values ​​above 350 ng / ml). laboratories calculate the median multiples (mom) and the results for maternal tests are compared with these moms. according to the axsym afp assay usage instructions, it is important for each laboratory to calculate its own moms since they deal with different population. a new version of axsym afp assay software is being developed to provide the automatic dilution protocol 1: 101, on the axsym instrument.
  • Acción
    All AxSYM AFP Reagents customers will be informed not to use the 1: 101 automatic dilution protocol.

Device

AXSYM AFP REAGENTS - Reg. No. 10055310293, list no. 7A48-22

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA