Events

Alerta De Seguridad para Modular Analyzers of Clinical Chemistry based on Immunological Assays: (1) Model E170, (2) Integrated Model E170. Catalog No.: 7656961, 7657009, 7657021, 7657900; all serial numbers.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnostics Corp [391899], 9115 Hague Rd, Indianapolis IN 46256 (distribuidor); Hitachi Ltd Ibaraki-Ken 312-8504, Japan (fabricante).

¿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
    692
  • Fecha
    2003-03-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Liquid may leak from the above mentioned analyzers, which may cause smoke) and / or damage to the units. the distributor notified by letter dated 18 october 2002.
  • Acción
    Make sure you received the Roche letter on October 18, 2002. Identify any affected product in your inventory. Until assembly / adjustment is complete, if you see or smell smoke, immediately turn off the system at the main switch, and call the Roche Technical Support Center. For additional information, schedule a technical visit in your area, and to arrange the units in your inventory, contact your local Roche representative. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Modular Analyzers of Clinical Chemistry based on Immunological Assays: (1) Model E170, (2) Integr...

Manufacturer

Roche Diagnostics Corp [391899], 9115 Hague Rd, Indianapolis IN 46256 (distribuidor); Hitachi Ltd...
  • Source
    ANVSANVISA