Alerta De Seguridad para SIMPLASTIN EXCEL - Lots: 161550, 161551, 161583, 161585, 161595, 161657, 161658, 161552, 161586, and 161596.

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.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 if there are any batches in your stock. If any, please contact BIOMÉRIEUX BRASIL S / A, by telephone 21 2444.1483 - Technical Assistance to Reagents, in order to make the return and consequently the replacement of the same. The UTVIG - Technovigilance Unit is monitoring the entire collection, return and replacement process until it closes. According to the company's statement, the termination of this payment is scheduled until August 26, 2003.
  • Causa
    Prolonged results in coagulation times. there is variation of the measured levels of vacuum remaining in the lyophilized vials. this vacuum failure was identified as the cause of the randomly altered clotting times in those batches. according to this information, the presence of atmospheric air together with an active principle would be the cause of the poor performance observed in certain batches.
  • Acción
    The company informs that a number of Corrective Actions have been implemented for both the Simplastin Excel S product lines and Simplastin Excel. These are: Vacuum control, bottle to bottle, more stringent, improvement of the bottle closure system in the production process and revision of the technical procedure sheets: In the instructions for use a check of the reconstitution of the freeze-dried tablets by the customer, as well as performing a double quality control test before using the vial for testing. Collection of products manufactured in the period from February 2000 to November 2002.


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