Events

Alerta De Seguridad para Etest Vancomycin / Teicoplamine X Polymyxin B, Registration No. 10158120623, lot: 1002338240 (Vancomycin / Teicoplamine) and lot 1002735070 (Polymyxin B).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIOMÉRIEUX Brasil S.A.; BIOMERIEUX 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
    1438
  • Fecha
    2014-10-03
  • 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
    According to the manifestation of the company, this does not compromise the quality of the product offered, but may negatively influence the susceptibility to antibiotics (Vancomycin / Teicoplamine and Polimixin B), which could lead to an incorrect or late antibiotic therapy decision. doctor responsible.
  • Causa
    The company holding the registration identified that there was a misunderstanding in the nationalization labeling of etest vancomycin / teicoplamine and polymyxin b. the vancomycin / teicoplamine products were labeled with the nationalization label containing the product polymyxin b. the company informs that both the printed boxes of both products, as the internal identification of the strips is correct. the problem occurred only in item nationalization labeling, affixed externally to products.
  • Acción
    The company that holds the registration in Brazil informs that it has forwarded an explanatory letter to all the customers and distributors who acquired the affected lots, as detailed instructions on how to proceed with the products covered by this field action. The company advises customers and distributors to evaluate their inventory and if they have kits with the problem informed above, to interrupt these batches and return the Notification form to the Customer Service Department so that the recall can be scheduled.

Device

Etest Vancomycin / Teicoplamine X Polymyxin B, Registration No. 10158120623, lot: 1002338240 (Van...

Manufacturer

BIOMÉRIEUX Brasil S.A.; BIOMERIEUX S.A