Events

Alerta De Seguridad para DRY REACTIVES VITROS * FOR PHBR, Registration No. 10132590518, lot: 2538-0060-7597 and lot: 2540-0063-4175

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1247
  • Fecha
    2013-04-01
  • 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
    According to the company's statement, the manufacturer considers that it is a situation in which the use or exposure to the affected product may cause adverse or reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote. If in doubt, the company requests that you contact the Technical Services to the Customer at 0800-728-7865 or 11 9 8223. See Customer Letter at: http://portal.anvisa.gov.br/wps/ content / Anvisa + Portal / Anvisa / Reports + Tecnicos / Menu + - + Alerts + and + Reports / Alerts + de + Tecnovigilancia
  • Causa
    The manufacturer company has identified in research that positive bias values ​​for patient samples, which may have been obtained, could not be detected by quality control fluids.
  • Acción
    The company that registers in Brazil is collecting the product and advises that: i) Discontinue use and discard all VITROS PHBR Slides remaining in your inventory; ii) Complete and return the Receipt Confirmation form (attachment); iii) Send this notification to all laboratories in your facility that use VITROS PHBR Slides; iv) Place this notification next to each VITROS System using the VITROS PHBR Slides or together with your VITROS user documentation.

Device

DRY REACTIVES VITROS * FOR PHBR, Registration No. 10132590518, lot: 2538-0060-7597 and lot: 2540-...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda