Events

Alerta De Seguridad para IMMULITE / IMMULITE 1000 Osteocalcin, Registration nº 10345161079 - Lots 316, 317 and 319.

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..

¿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
    1383
  • Fecha
    2014-05-02
  • 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
    The company reports that, based on research conducted, Osteocalcin may serve as a measure of increased bone resorption in some patients. Depending on the treatment approach, osteocalcin dosing may be correlated with therapy. In some patients the risk of osteoporosis correlates with increased osteocalcin values. Low recovery of osteocalcin is not expected to impact treatment.
  • Causa
    Siemens has confirmed an average low 50% recovery in patient values ​​over the entire reported range of the immulite / immulite 1000 osteocalcin (lkon1) test in the lots listed above, and the bias may not be detected by the quality control material.
  • Acción
    The company informs that customers were instructed to discontinue use of affected lots; to segregate remaining units in their inventories to collect them; discuss the alert message with the person in charge of the laboratory in order to evaluate the need to review previously released results; to complete the effectiveness verification form and to keep the letter filed with the laboratory records. For more information, see Annex I - Customer Letter.

Device

IMMULITE / IMMULITE 1000 Osteocalcin, Registration nº 10345161079 - Lots 316, 317 and 319.

Manufacturer

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