Events

Alerta De Seguridad para Fibriquik - Lot: 111169 and Fibriquik Thrombin Reagent - Lots: 113049, 113050

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
    781
  • Fecha
    2004-08-31
  • 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
    Check your stock, if you have stocked kits, collect and return immediately to the company, correctly filling out the return certificate sent by the company. For more information, contact BIOMERIEUX BRASIL S / A by telephone at (0xx21) 2444.1400 . The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
  • Causa
    High and unexpected values ​​of controls using fibriquik.
  • Acción
    The company informs that it has received some customer reports regarding the high and unexpected values ​​of the controls using Fibriquik. These reports were confirmed during the internal investigations. It was found that the altered values ​​are due to low levels of thrombin activity in the flask, causing prolonged coagulation times and some imprecision. However, internal research has shown that this does not compromise patient outcomes. Detailed internal studies were performed to demonstrate that international standards, label values, and plasma levels of patients recovered from standard curves using Fibriquik that have less activity than standard thrombin are comparable to those obtained with Fibriquik that has normal levels of thrombin activity . Since we identified products with lower than normal levels of thrombin activity, which could cause undesirable imprecision, we request that the use of the aforementioned Fibriquik batches be suspended.

Device

Fibriquik - Lot: 111169 and Fibriquik Thrombin Reagent - Lots: 113049, 113050

Manufacturer

BIOMERIEUX BRASIL S/A
  • Source
    ANVSANVISA