Events

Enzygnost® Anti-VZV / IgG - Registration number: 10345161685 - Risk class II (Products of medium risk to the individual and / or low risk to public health, subject to registration) - Lots: 44218; 44309; 44565; 45077. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 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
    1695
  • 날짜
    2015-10-22
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    The company recommends discontinuing the use of the Enzygnost Anti-VZV / IgG product.
  • 원인
    Lots 44309; 44565; 45077 of the enzygnost anti-vzv / igg product may exhibit a greater variation of homogeneity. this can lead to invalid races because they do not meet the p / n reference validation criteria at the beginning and end of the series. this issue may lead to an underestimation of the immunity status measured by the titration levels as the absorbance values ​​of samples with falsely low results. the risk of false negative results is unlikely but can not be totally excluded. when monitoring a potential infection by changing the title level over time with repeated design, the variance of the levels may be higher than expected. in rare cases, this can lead to a title change.
  • 조치
    The company that holds the registration is promoting the "Discontinuation of use" of the product. (Attached Letter to Clients). PI Code 15-019.

Device

Enzygnost® Anti-VZV / IgG - Registration number: 10345161685 - Risk class II (Products of medium ...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH