Events

Alerta De Seguridad para TREPANOSTIKA TP RECOMBINANT - Registration ANVISA nº 10158120502, Reference 285034 - Lots D37FA and D37FB, Reference 285035 - Lots D37FA and D37FB - Validity: 06/2007, 07/2007 and 08/2007

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

¿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
    852
  • Fecha
    2007-01-10
  • 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 after risk assessment, it reiterates that there is no sanitary impact, since in case of occurrence of the problem, the race is given with invalid. He also states that there was no question from the customers who purchased the product. For further clarification, please contact your local representative or the customer service department - Biomérieux 0800264848. The Company, through a file sent to UTVIG dated March 16, 2007, informs the closing of the collection.
  • Causa
    There is an increased risk that the absorbance of the negative control, whether very high - negative control is not within the qualification values, as described in the instructions for use.
  • Acción
    The company informs that it is taking all steps to solve the problem and decided: 1 - Block the commercialization of the lots, 2 - Inform its clients the collection of lots by means of notification (letter).

Device

TREPANOSTIKA TP RECOMBINANT - Registration ANVISA nº 10158120502, Reference 285034 - Lots D37FA a...

Manufacturer

BIOMÉRIEUX BV
  • Source
    ANVSANVISA