Events

Alerta De Seguridad para ID-DiaCell I, II, III (Code 004310) Lot 45181.24.1; ID-DiaCell ABO / I, II (Code 003610) Lot 45001.24.1; ID-DiaCell ABO / I, II, III (Code 003618) Lot 45011.24.1; ID-DiaPanel (Code 004114) Lot 45161.46.1; ID-DiaCell I, II (Code 003613) Lots 45151.45.1 and 45151.46.1; ID-DiaCell ABO (A1, A2, B) (Code 003617) Lot 45081.24.1; ID-DiaCell ABO (A1, B) (Code 003624) Lot 45091.24.1; ID-DiaCell POOL (Code 003630) Lot 06070.63.1; DiaCell-MP ABO (A1-B) (Code 109897) Lot 45422.24.1. ANVISA registration no. 80004040131 (products registered in the same family).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por DIAMED LATINO AMERICA SA..

¿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
    1342
  • Fecha
    2013-12-19
  • 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
    False negative results of anti-FYa and anti-Fyb may represent a significant risk for patients with sickle cell anemia, since the index of these antibodies is usually high in these patients. Check additional information in the Alert Message posted by the company at (WAITING FOR PUBLICATION).
  • Causa
    Reduced reactivity for some antigens (fya, fyb and mns), which can lead to false negative results.
  • Acción
    ASK QUICKLY in your inventory of the products at risk, segregate them and avoid their use. Check the following steps of manufacturer communication, product destruction and refund in the Company Alert Message (see link in the Clarification field).

Device

ID-DiaCell I, II, III (Code 004310) Lot 45181.24.1; ID-DiaCell ABO / I, II (Code 003610) Lot 4500...

Manufacturer

DIAMED LATINO AMERICA SA.