Events

Alerta De Seguridad para FLEX REAGENT FOR C REATIVE PROTEIN REVISED DIMENSION. ALL LOTS. REGISTRATION No. 10321170395.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Dade Behring Ltda/Siemens; Siemens Healthcare Diagnostics Inc..

¿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
    927
  • Fecha
    2008-06-18
  • 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 holding the registration in Brazil, the test may result in falsely elevated results when used with plasma samples collected in EDTA tubes. Lithium heparin plasma and serum can be used equivalently.
  • Causa
    Occurrence of falsely high values ​​of the flex reagent cartridge for dimension revised c reactive protein.
  • Acción
    Dade Behring Ltda. Recommends users not to use any batch of Dimension Revised Reactive C Protein Flex Reagent in conjunction with EDTA blood collection devices for sample collection and testing for RCRP. Lithium heparin serum and plasma remain acceptable types for use with the RCRP method. According to the company, communication letters have already been sent to all the customers involved.

Device

FLEX REAGENT FOR C REATIVE PROTEIN REVISED DIMENSION. ALL LOTS. REGISTRATION No. 10321170395.

Manufacturer

Dade Behring Ltda/Siemens; Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA