Events

Alerta De Seguridad para LIVES HBsAg ULTRA. Registered N °: 10158120583. Lot Affected: 820592901.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomerieux Brasil S.A..

¿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
    937
  • Fecha
    2008-08-02
  • 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
    Inside the kit are two silver packs containing the cones. In this case, some of the VIDAS HBsAg Ultra product packs were filled with VIDA CK-MB kit cones and labeled as VIDAS HBsAg Ultra.
  • Causa
    Some product units belonging to lot 820592901 were filled with material from a different diagnostic kit (vidas ck-mb) and labeled as vidas hbsag ultra.
  • Acción
    Biomérieux Brasil SA has already started, through communication letters, the contact with the clients involved. The collection of affected products in Brazil has also been started by the company. The recommendations to the users are as follows: (1) for all the tests carried out with the product (of the lot under risk) and that presented NEGATIVE result, to contact the patients and to arrange a new test; (2) Immediately verify in stock the existence of lot no. 820592901 of the product; (3) If products of the batch in stock are located, segregate the products at risk and identify them immediately in order to avoid their use; (4) Contact the company through the Product Pickup Notification Letter; (5) Confirm, prior to the laboratory analysis and regardless of the batch number, whether the color of the BARRETE is the same as that of the CONE.

Device

LIVES HBsAg ULTRA. Registered N °: 10158120583. Lot Affected: 820592901.

Manufacturer

Biomerieux Brasil S.A.