Alerta De Seguridad para QUIKLYTE DILUTION TESTER, Model 1x50mL; registration: 10345161157, risk class: I - products that present minimal risk to the user. Serial / Lot Number: 4MD707.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos Ltda.,; Siemens Healthcare Diagnostics Inc..

¿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
    1559
  • Fecha
    2015-03-26
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    According to the company, the health risk is related to a potential correction of up to 5% in the sodium parameter, which may generate a lower result than expected
  • Causa
    Presence of positive bias, possibly above 5%, which may result in unnecessary fault or correction in dilution check. dilution check failure prevents the complete installation of the quiklyte integrated multisensor.
  • Acción
    According to the registry holder, customers were advised of the following recommendations: • Discontinue use and discard the product from the batch involved. • Review the letter with the laboratory officer. • Review inventory / inventory of this product to determine replacement requirements. • Complete Field Action Effectiveness Check Form. It was not recommended to review the results previously generated by the laboratory.

Manufacturer