Alerta De Seguridad para ADVIA CENTAUR HCV - registry 10345160632 - Affected lots: 79643226, 79713226, 84770229.

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..

¿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
    Investigations did not demonstrate statistical difference in agreement between the specificity of listed lots and recent batches of HCV kit. However, differences between the increased rate of observed reactive outcomes vary between laboratories and can be attributed to demographic differences in patient populations. The internal test showed that the estimated specificity agreement for finished batches at 226, 227, 228 and 229 was 99.76% with 95% confidence interval (CI) of 99.43-99.92%. As indicated in the Instructions for Use (UI), the specificity assigned to the ADVIA Centaur HCV assay is 99.90% with 95% confidence interval (CI) of 99.78-99.97%. People whose HCV positive results require more specific additional tests to confirm the presence of virus, viral load and genotype in order to facilitate appropriate therapy. Therapy is not indicated based solely on the immunoreactivity of IgG antibodies to HCV. Therefore, the health risk is absent. As indicated in the Instructions for Use, for samples considered to be reactive to HCV IgG antibodies, it is recommended that the sample be duplicated in duplicate; and if 2 of 3 results are greater than or equal to the Reference Value, the sample is considered reactive and supplemental testing is recommended. There are no health risks, according to the Good Laboratory Practices, positive results should be sent to confirmation before being released to patients, whose tests must be repeated in reference methodology. People whose results were positive for HCV require more specific additional tests to confirm the presence of virus, viral load and genotype in order to facilitate appropriate therapy. Therefore, the therapy is not indicated based solely on the immunoreactivity of IgG antibodies to HCV. Anvisa follows this action.
  • Causa
    Siemens healthcare diagnostics has identified an increase in the rate of reactive results for hcv that do not confirm as reactive after further testing (riba, pcr).
  • Acción
    Siemens recommended that customers and distributors order ADVIA Centaur HCV (aHCV) kits from batches terminated at 230 or above as replacement of the existing material in their inventories. In the meantime, customers were informed of the possibility of continuing to use ADVIA Centaur HCV (aHCV) of the lots cited, according to the algorithm test provided in the Instructions for Use. When performing the algorithm test documented in the Use Instruction, a review of the previously reported ADVIA Centaur HCV result is not warranted. However, Siemens recommended that the technical area of ​​this customer review the information contained in the report sent to their respective Laboratory Directors. If there is any doubt or need for additional information, the Siemens Customer Support Center contact will be made available. You have been requested to complete and send the Effective Verification Form sent along with the notification letter. You have also been asked to send the notification to everyone that these distributors and customers may have distributed the product.


  • Empresa matriz del fabricante (2017)
  • Source