Events

Safety Alert for ADVIA CENTAUR HCV - registry 10345160632 - Affected lots: 79643226, 79713226, 84770229.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1145
  • Date
    2012-06-25
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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).
  • Action
    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.

Device

ADVIA CENTAUR HCV - registry 10345160632 - Affected lots: 79643226, 79713226, 84770229.

Manufacturer

Siemens Healthcare Diagnósticos Ltda.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA