Events

Alerta De Seguridad para PSA Third Generation IMMULITE® / IMMULITE® 1000 - Registration 10345160987. Lots: 320 and 321.

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 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
    1291
  • Fecha
    2013-09-03
  • 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 analysis identified that the severity is insignificant, because as the controls of the assay are out of range, adjustment will occur, preventing the release of patient results. There is no impact to patient samples when values ​​are not reported, so this action is classified as without health risk. Letter to the client: http://portal.anvisa.gov.br/wps/wcm/connect/6c0ba8804115b1d2aed3af0ea338d2ac/Carta_aos_clientes_+IMC_13_20.pdf?MOD=AJPERES
  • Causa
    Adjustment faults with the 3rd generation immulite® / immulite® 1000 psa kits (lkup1) of batches 320 and 321. some kits may contain committed (lupl / h) patch paths of lot 0126, which may lead to adjustment faults and / or exceed the established interval. if the adjustment is correct, the quality control results within the established range, the kit can be used to release patient results.
  • Acción
    Customers were instructed to discontinue use of the product, segregate any remaining stock from the affected lot of the Third Generation IMMULITE® / IMMULITE® 1000 PSA in order to return these products to Siemens and keep the letter with the laboratory records.

Device

PSA Third Generation IMMULITE® / IMMULITE® 1000 - Registration 10345160987. Lots: 320 and 321.

Manufacturer

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