Events

Alerta De Seguridad para Actin® Activated Cephaloplastin Reagent, 2 x 10 ml Pack - Registration 10345161140 - lot 557116

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 Ltda.; Siemens Healthcare Diagnostics Products GmbH.

¿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
    1682
  • Fecha
    2015-09-01
  • 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
    Siemens confirmed for TTPa: variation greater than 3 seconds in the normal range and / or greater than 15% in the pathological range with the product at validity. It is possible that samples with values ​​close to the medical decision point may present deviations in the ranges: normal up to 4 seconds and pathological up to 33%. The upward trend of aPTT in most cases will be recognized by controls outside the designated range.
  • Causa
    Siemens healthcare diagnostics has confirmed internally that for lot 557116 the values ​​of the controls may be outside the designated ranges. in addition, it was observed that the results of the normal control presented values ​​with a tendency of high. this indicates change of product performance even within the validity.
  • Acción
    The company advises you to discontinue use and also discard any and all remaining material from the above-mentioned batch of Dade Actin Activated Cephaloplastin Reagent. This field action has the same content as the action communicated through alert 1569; the company's quality department identified the same problem in this lot, which generated this new field action.

Device

Actin® Activated Cephaloplastin Reagent, 2 x 10 ml Pack - Registration 10345161140 - lot 557116

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA