Events

Name of the product: ADVIA CENTAUR TnI ULTRA /// Record number: 10345160531 /// Affected: 100 tests - lots: 24483099; 28137099; 36527099; 4,251,6099; 46626101; 5,965,5103; 53539104; 72936105; 81676105; 89385106; 94642106. 500 tests - Batches: 24479099; 26294099; 4,320,5101; 46929101; 5,780,5103; 65432103; 52590104; 73322105; 80480105; 86319106; 94250106 / / / Product hazard class: II. 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 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
    1920
  • 날짜
    2016-06-28
  • 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
    This problem is not expected to impact the diagnosis or treatment. The ability of the assay to detect the decrease or serial increase of TnI-Ultra will not be impacted; therefore, it is not necessary to review the results of previous tests or to perform repeated tests of the previously reported results.
  • 원인
    Siemens healthcare has forwarded to anvisa the cc 16-12 field action stating that the advia centaur tni ultra product exhibits a greater than 10% change in results from samples with biotin levels greater than 10 ng / ml (41 nmol / l) .
  • 조치
    Field Classification: Letter to the Client /// Field action code: CC 16-12 /// Recommendations to users and patients: continue to use the TnI-Ultra ADVIA Centaur assay. Be careful of patients taking biotin supplements that may exhibit a small increase in TnI-Ultra results; however, the ability of the assay to detect the increase or decrease in TnI is maintained.

Device

Name of the product: ADVIA CENTAUR TnI ULTRA /// Record number: 10345160531 /// Affected: 100 tes...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.