Events

Alerta De Seguridad para CORTISOL IMMULITE, Kit for 100 tests, Registration 10345160665, lots 381, 382 and 383

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 Ltd.

¿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
    1442
  • Fecha
    2014-10-17
  • 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 overseas manufacturer performed the problem analysis, evaluating all the inherent risks that generated the corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as without health risk, its severity being low and its probability of occurrence unlikely. The positive bias observed in cortisol values ​​may potentially lead to further investigation of the status of the adrenal gland. The overall health risk is negligible. Siemens does not recommend a previous review of the results for this reason.
  • Causa
    Siemens healthcare diagnostics has confirmed that the immulite / immulite 1000 cortisol kits 381, 382 and 383 demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. positive bias has also been observed in quality control materials and may result in values ​​outside the stated ranges.
  • Acción
    The company advises customers to stop using the product, segregate any remaining stock from the affected lots of CORTISOL IMMULITE with the intention of returning these products to Siemens and to keep the letter with the laboratory records.

Device

CORTISOL IMMULITE, Kit for 100 tests, Registration 10345160665, lots 381, 382 and 383

Manufacturer

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