Events

Alerta De Seguridad para SLIDEX STAPH KIT. Anvisa registration number: 10158120557. Affected lots: 10051 and 73113.

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 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
    1025
  • Fecha
    2010-06-24
  • 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 Biomerieux, the company decided to collect batches 73112 and 73113 from the Slidex Staph Kit as a result of a failure in the product release process: the aforementioned lots were released for commercialization in the national territory before the end of the analyzes carried out in the laboratory. quality control of the company. The Technovigilance Unit is following up on this case. #### The company informed UTVIG on 10/27/2010 about the completion of the field action, with collection of the affected units and the presentation of the certificate of destruction of the same.
  • Causa
    Some batches of the product were marketed without the approval of the company's quality control area.
  • Acción
    Users of the product should perform the following actions: (1) Verify in their inventory the presence of affected lots; (2) If a product is identified as being at risk, it must be segregated and the manufacturer informed. The company said it had already sent warning letters to its customers, stating the problem. The product is being collected from the market by Biomerieux.

Device

SLIDEX STAPH KIT. Anvisa registration number: 10158120557. Affected lots: 10051 and 73113.

Manufacturer

BioMerieux Brasil SA.