ADVIA Centaur HCV (Anvisa Record No. 10345160632). Affected lots in Brazil: 79643226, 79713226 and 84770229. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnostics Inc; Siemens Healthcare Diagnósticos Ltda 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1139
  • 날짜
    2012-06-14
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Risk assessment presented by Siemens Healthcare Diagnósticos Ltda: Investigations did not demonstrate statistical difference in agreement between the specificity of listed lots and recent batches of the 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. Therefore, according to the company, there are no health risks. Positive results should be forwarded for confirmation before being released to patients, whose tests should 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.
  • 원인
    Siemens has identified an increase in the rate of reactive results for hcv that do not confirm as reactive after further testing (riba, pcr).
  • 조치
    Check for any affected batches in your stock, segregate the affected products and request replacement of the ADVIA Centaur HCV (aHCV) kits for Siemens. Fill out and send to Siemens the Effectiveness Verification Form, which is an integral part of the Alert Message disclosed by the company (available at http://portal.anvisa.gov.br/wps/wcm/connect/c0d53d804b9dfafdb5e0b7af8fded4db/Carta_aos_Clientes_e_Formulario_de_Verificacao_de_Efetividade.pdf ? MOD = AJPERES). Pass this alert and other information you have received from Siemens to all those to whom you have distributed the product in question. The company recommends that the technical area of ​​its clients review the information contained in the report sent with the laboratory directors. If there is any doubt or need for additional information, the company should be contacted.

Manufacturer