Events

Alerta De Seguridad para Trade name: Blood Agar Technical Name: Blood Agar ANVISA Registration Number: 10158120601 Hazard Class: I Affected Model: Serial Numbers Affected: 1604112739

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 Ind. E Com. De Prod. Laboratoriais Ltda..

¿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
    2073
  • Fecha
    2016-07-29
  • 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
    If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    According to the company, on 03/06 the company received the first complaint from a distributor because it had found 64 packets of plaque with bacterial contamination. these plates were returned to biomérieux brazil and the qc laboratory made comparative tests between samples received and samples received from the distributor. at that time the level of contamination found in the samples that returned from the market was still within the specifications of the product, since the ready-to-use medium plates have reduced bioburden and are not a sterile product. product specification for aql contamination is 1.0%. total number of plates manufactured in this lot 90910, which in function of aql of 1.0%, would allow to have up to 909 plates with some contamination. after this event the manufacturer received 4 more customer complaints about the same fact. after receiving the 3rd complaint the company identified that the% of contamination of the lot had extrapolated the maximum limit allowed by the aql of 1.0%. in this way, the company decided to make the present communication to anvisa, despite the risk to the patient / user in this case being very low.
  • Acción
    Field Action Code Agar Blood Lot: 1604112739 triggered under the responsibility of bioMérieux company. Company will provide guidance to customers.

Device

Trade name: Blood Agar Technical Name: Blood Agar ANVISA Registration Number: 10158120601 Hazard ...

Manufacturer

bioMérieux Brasil Ind. E Com. De Prod. Laboratoriais Ltda.