Events

Alerta De Seguridad para kit AxSYM TROPONIN - I Reagent. Lot: 90172M300

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil 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
    709
  • Fecha
    2002-10-03
  • 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
    Abbott Laboratories is working to speed up product replacement. ///////// NOTE: Are all results between 0.5 and 2.0 ng / mL suspect? - No, only some apparently healthy patients can show results between 0.5 and 2.0 ng / ml. Consider that for the diagnosis in myocardial infarction, an initial result of AxSYM TROPONINE - I Reagent. Lot: 90172M300, should be analyzed in conjunction with other cardiac markers (CK-MB, Myoglobin), ECG, symptoms and signs, etc.
  • Causa
    Possible increase in the frequency of results above 0.5 ng / ml (from 0.6 to 2.5 ng / ml) in apparently healthy patients. these results, initially above 0.5 ng / ml, once retested present results below 0.5 ng / ml. this possibility was not observed in patients with a confirmed diagnosis of acute myocardial infarction.
  • Acción
    Discontinue use of AxSYM TROPONIN - I Reagent. Lot: 90172M300.

Device

kit AxSYM TROPONIN - I Reagent. Lot: 90172M300

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA