Events

Alerta De Seguridad para ADVIA CENTAUR TSH3-Ultra (TSH3-UL) - Registration No. 10345161732 ;. REAGENT FLEX TSH DIMENSION - Registration No. 10345161255 ;. TSH THIRD GENERATION IMMULITE / IMMULITE 1000 - Registration No. 10345160833 ;. TSH 3rd GENERATION IMMULITE 2000 - Registration No. 10345160834

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 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
    1273
  • Fecha
    2013-07-18
  • 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
    See the instructions for use of each product for more information. Consult the National Academy of Clinical Biochemistry: Laboratory Support for the Diagnosis and Monitoring of Thyroid Diseases: Guide # 18 for additional information on investigations of discordant TSH values. If you have any questions or need additional information, please contact the Customer Support Center at 0800-129-633. Link: Letter to the customer - http://portal.anvisa.gov.br/wps/wcm/connect/1ba0a0004066b7f78293d2dc5a12ff52/Carta_CC_13_06.pdf?MOD=AJPERES
  • Causa
    A rare variant of tsh, identified in a small group of patients, is not detected by the following siemens assays: advia centaur® systems tsh3 ultra 100t, 500t, 2500t; dimension® thyroid stimulating hormone; dimension loci® thyroid stimulating hormone; immulite® systems third generation tsh 100t, 500t; immulite® 2000 / immulite® 2000 xpi third generation tsh 200t, 600t; immulite systems rapid tsh 100t, 500t; immulite 2000 / immulite 2000 xpi rapid tsh 200t, 600t.
  • Acción
    Siemens Healthcare Diagnostics is informing its customers

Device

ADVIA CENTAUR TSH3-Ultra (TSH3-UL) - Registration No. 10345161732 ;. REAGENT FLEX TSH DIMENSION -...

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA