Events

Alerta De Seguridad para Trade Name: Glucose Technical Name: Glucose ANVISA Registration Number: 80046190076 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: Glucose BioSystems, code 11504; Affected Lot: 14560.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por EUROTECH PRODUTOS LABORATORIAIS E SERVIÇOS LTDA ME; BIOSYSTEMS 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
    2117
  • Fecha
    2016-11-08
  • 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
    It has been recommended to the end user that the product is not used.
  • Causa
    The manufacturer of the product glucose biosystems, code 11504; lot 14560 found that some units of the batch referenced did not contain glucose reagent but uric acid. based on the investigations, it was confirmed that the batch mentioned above has a labeling error.
  • Acción
    Field Action Code triggered under the responsibility of the company EUROTECH LABORATORY PRODUCTS AND SERVICES LTDAME. Company will collect for later incineration.

Device

Trade Name: Glucose Technical Name: Glucose ANVISA Registration Number: 80046190076 Hazard Class:...

Manufacturer

EUROTECH PRODUTOS LABORATORIAIS E SERVIÇOS LTDA ME; BIOSYSTEMS SA
  • Source
    ANVSANVISA