Events

Alerta De Seguridad para VITEK 2 AST-YS 07. ANVISA Registration No. 10158120592.

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

¿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
    1552
  • Fecha
    2015-04-22
  • 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 risk assessment carried out by the company, the SEVERITY of the potential consequences for patients of incorrect or delayed results may be considered CRITICAL, which may lead to permanent deterioration, high impact on the patient's health or even death . The probability of occurrence was determined by the company as OCASIONAL, which means "possible to occur a few times during the product life cycle." The general risk posed by the company is MODERATED in a general way. relevant in Brazil since Flucitosycin is not used as therapy in case of fungemia (as it appears in the technical literature available in the market).
  • Causa
    During the quality control tests to be performed by the clients, it was identified that strain atcc 6258 - candida krusei, naturally resistant to the antibiotic flucitosina, presented results outside the minimum range required for such antibiotic, which means a sensitive result for flucitosina.
  • Acción
    The company has already started communicating with its customers, alerting to the problem in question and is developing a new formulation for the product, which should be available within 6 months. Identify if you have products at risk in stock and carefully read the letter disclosed by the company, to take the necessary steps - letter available at http://portal.anvisa.gov.br/wps/wcm/connect/bae52680481c317688dfadbdc15bfe28/Notifica%C3 A + A + + + + + + + + + + + + + + + + + + + + + + + A9rieux.pdf • MOD = AJPERES)

Device

VITEK 2 AST-YS 07. ANVISA Registration No. 10158120592.

Manufacturer

Biomerieux Inc.