Events

Alerta De Seguridad para Product name: CK-MB IMMULITE Technical name: ISOENZIMA CREATINOQUINASE ACTIVITY Registration number ANVISA: 10345161894 Hazard class: III Affected model: Kit for 100 or 500 tests. Lot / Serial Number Affected: Lot: 3400

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 S.A; 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
    2098
  • Fecha
    2016-09-15
  • 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
    Siemens recommends a review of CK-MB results generated in the last 24 hours. Repetition of these samples when CK-MB values ​​are elevated above the 99th percentile is recommended provided the sample is within the specified storage and time conditions by the Instruction of Use (IFU). Discontinue use of lot 340.
  • Causa
    Siemens has confirmed that patient and quality control samples may have a positive bias greater than 43% when using the immulite / immulite 1000 ck-mb 340 ck-mb kit lot when the kit nears the end of its useful life. positive bias can lead to quality control values ​​exceeding set intervals. the problem impacts only the ck-mb immulite / immulite 1000 assay.
  • Acción
    Field Action Code BMI 16-24 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Product name: CK-MB IMMULITE Technical name: ISOENZIMA CREATINOQUINASE ACTIVITY Registration numb...

Manufacturer

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