Events

Alerta De Seguridad para CREATININE REAGENT CREATES DIMENSION. Anvisa Registry n ° 10345161408.

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 DIAGNÓSTICO S.A.; 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
    1674
  • 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
    Identify affected products in your inventory. If you have any product affected by this field action, check the Urgent Security Notice information in DC Field 15-06 (15-41) and the Corresponding Field Action Effective Verification Form, both of which are sent by the company to its customers . Fill out the Effective Field Action Verification Form and send it to SIEMENS HEATHCARE DIAGNÓSTICO SA. Evaluate the letter information with your team, review your procedures for creatinine results for hemolyzed samples, and update your protocol information regarding hemoglobin interference if necessary in the results. The Urgent Security Notice is available at: http://portal.anvisa.gov.br/wps/wcm/connect/f4d7460049baed08b4c9beda875a0177/Carta_1674+15-06.pdf?MOD=AJPERES
  • Causa
    The product dimension® creatinine (crea) may present decreased results of up to 12.7% (or approximately 0.2 mg / dl [18 μmol / l]) for a creatinine result of 1.5 mg / dl [133 μmol / l] when hemolysis exceeds 300 mg / dl [0.19 mmol / l] hemoglobin.
  • Acción
    Sending safety information, by SIEMENS HEALTHCARE, to customers who own the product. Alert message available at: http://portal.anvisa.gov.br/wps/wcm/connect/f4d7460049baed08b4c9beda875a0177/Carta_1674+15-06.pdf?MOD=AJPERES

Device

CREATININE REAGENT CREATES DIMENSION. Anvisa Registry n ° 10345161408.

Manufacturer

SIEMENS HEALTHCARE DIAGNÓSTICO S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA