Events

ADVIA Centaur HIV 1/0/2 Enhanced (EHIV), registry: 10345161854, risk class IV; series: 44563141; 4,550,2141; 47542143; 4,844,414; 5,146,245; 52901147. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Inc 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
    1592
  • 날짜
    2015-05-22
  • 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
    According to the manufacturer, the probability of reporting an erroneous result (reactive or non-reactive) is unlikely, as this can be detected by quality control. The results of patients obtained with this assay are acceptable if they are followed by valid quality control results.
  • 원인
    Product quality control results out of the expected range. the registry subject relates the issue to the decrease in onboard stability of the ehiv assay reagent.
  • 조치
    The company will perform an update / correction of the instructions for use. Guidance is that if quality control results are not out of the expected ranges, no action is required. If quality control results are obtained outside the expected range, it is recommended that: a. Recalibrate the test every 7 days; B. Replace the reagent cartridge every 14 days. MORE INFORMATION IN THE LETTER TO THE CLIENT ATTACHED

Device

ADVIA Centaur HIV 1/0/2 Enhanced (EHIV), registry: 10345161854, risk class IV; series: 44563141; ...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Inc