Events

Alerta De Seguridad para ATB - DENSITOMETER CONTROL DEVICE, Mark: Biomerieux, Registration: 10158120674, lots 1003780430, 1003838260, 1003848040, 1003883560, 1003990940, 1004089920.

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.; Biomerieux 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
    1746
  • Fecha
    2015-11-12
  • 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 the company the problem may cause a failure to control the calibration of the Densimat instrument, potentially leading to false susceptibility or false identification results. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
  • Causa
    Performance failure, with change in performance, in the lots described for the product atb- densitometer control device. in this case, the calibration check of the densimat equipment may fail.
  • Acción
    The company will collect and destroy the products. A letter will be forwarded to all customers who have purchased the affected lots, with detailed guidance on how to proceed with the product covered by this field action. The company directs you to stop using the affected product and fill out the Notification form to notify the company of any remaining stock of the kit. The company's recommendation is that until the manufacturing of new lots, the Mc Farland standard scale can be used as a back-up solution. A new batch of the product was released to replace the nonconforming product. Additional batches will be available for allocation until the breach situation is resolved. As soon as stock is normalized, bioMérieux will contact customers.

Device

ATB - DENSITOMETER CONTROL DEVICE, Mark: Biomerieux, Registration: 10158120674, lots 1003780430, ...

Manufacturer

Biomerieux Brasil SA.; Biomerieux S. A