Events

Alerta De Seguridad para Technical Name: TOXOPLASMA GONDII Registration Number ANVISA: 80146501651 Hazard Class: III Affected Model: Not applicable Serial Numbers Affected: 64245LI00; 66063LI00; 67003LI00; 68443LI00; 69252LI00; 70171LI00; 66066LI00; 67006LI00; 68444LI00; 69253LI00 and 70174LI00.

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; Inpeco 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
    2162
  • Fecha
    2016-12-13
  • 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
    Review this release with your Medical Director. Additional tests with a secondary method are recommended to confirm the reactive results (= 0.60 Index or = 1.00 S / CO) for samples from immunocompromised or newborn infants or umbilical cord blood samples and other samples with expected low concentrations of IgM . Keep this notice in your lab files
  • Causa
    For the architect toxo igm assay, an increase in false gray and / or reactive zone results was observed for samples from immunocompromised or newborn patients, as well as umbilical cord blood samples with batches indicated above. these types of samples have a low total igm titer in common. internal studies with the architect toxo igm assay have demonstrated that samples from pregnant women and serum and plasma samples from blood donors are not impacted and meet the specificity specifications of the assay. abbott has identified a solution to the problem and plans a product modification for the first quarter of 2017.
  • Acción
    Field Action Code FA14NOV2016 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

Technical Name: TOXOPLASMA GONDII Registration Number ANVISA: 80146501651 Hazard Class: III Affec...

Manufacturer

Abbott Laboratórios do Brasil; Inpeco S.A.
  • Source
    ANVSANVISA