Events

Alerta De Seguridad para Two products are affected by the field action. 1. Trade name: RUBELLA IGM IMMULITE / IMMULITE 1000 - Technical name: Rubella virus - Register 10345160740 - Affected lot (s): 333 and 334. ///. 2. Trade name: RUBEOLA IgM IMMULITE 2000 - Registration 10345160813 - Affected lots: 237, 236M, 238, 239 ///. Risk Class: III - Products that present a high risk to the user, the patient and / or the public health

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
    2009
  • Fecha
    2016-10-25
  • 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
    Recommendation to Users and Patients: Siemens recommends moving to IMMULITE / IMMULITE1000 Rubella IgM Kit 0337 lot or to IMMULITE 2000 / IMMULITE 2000 XPi Rubella IgM Kit lots 240 and above. A review, including retesting samples that are still in the time and storage conditions specified in the Instructions for Use, is recommended for non-reactive results = 0.47 to <0.9 previously generated. Retesting using Rubella IgM or another appropriate Rubella 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 patient samples for batches of rubella igm reagents for immulite® / immulite® 1000 and immulite® 2000 / immulite® 2000 xpi systems. these samples may display a percentage of coefficient of variation (% cv) greater than the precision performance data published in the instruction for use in non-reactive, indeterminate and reactive indexes.
  • Acción
    Field Action No. BMI 16-20 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company issued Letter to Customers.

Device

Two products are affected by the field action. 1. Trade name: RUBELLA IGM IMMULITE / IMMULITE 100...

Manufacturer

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