Events

Alerta De Seguridad para Trade name: IMMULITE / IMULLITE 1000 CMV IgM; IMMULITE 2000 / IMMULITE 2000 XPi CMR IgM Technical Name: IMMULITE / IMULLITE 1000 CMV IgM; IMMULITE 2000 / IMMULITE 2000 XPi CMR IgM Registration number ANVISA: 10345161051; Affected batch / series numbers: IMMULITE / IMMULITE 1000 CMV IgM Lots: 330,331 IMMULITE 2000 CMV IgM Lots: 255; 256; 257; 258; 259; 260; 261; 262; 263; 264; 266.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A,; Siemens Healthcare Diagnostics Products Ltd.

¿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
    2094
  • Fecha
    2016-09-30
  • 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
    Siemens recommends the transition to kit lot 0332 and above for CMMI IgM IMMULITE / IMMULITE 1000 and kit lots 268 and above for CMMI IgM IMMULITE 2000/2000 XPi. A revision, including retesting samples that are still in the storage time conditions specified in the Usage Instruction, is recommended for non-reactive results = 0.47 to <0.9 previously generated. Retesting using CMV IgM or another appropriate CMV assay should be considered, will depend on the clinical context and the time of the initial test performed.
  • Causa
    Siemens healthcare diagnostics has confirmed an increase in inaccuracy in some patients with lots of cmv igm reagents for the mmulite / immulite 1000 and immulite 2000 / immulite 2000 xpi systems. these samples may exhibit a high percentage of coefficient of variation (% cv) when compared to the precision performance data published in the instruction of use, through the indices of non reactive, indeterminate and reactive.
  • Acción
    Field Action Code BMI 16-22 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: IMMULITE / IMULLITE 1000 CMV IgM; IMMULITE 2000 / IMMULITE 2000 XPi CMR IgM Technical...

Manufacturer

Siemens Healthcare Diagnósticos S.A,; Siemens Healthcare Diagnostics Products Ltd
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA