Events

Trade name: ADVIA CENTAUR CA 19-9 Technical name: ANTIGEN CA 19-9 Registration number ANVISA: 10345161747 Hazard class: III Affected model: Kit for 50 tests; 250 test kit Serial numbers affected: 94990382, 39741386, 51303388, 82030380, 86322380, 6712382, 39742386, 48671388, 51673388, 60175390, 33687386, 80293380, 87147380 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
    2083
  • 날짜
    2016-11-18
  • 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
    For clients who use the CA 19-9 trial in the ADVIA Centaur CP and ADVIA Centaur / XP / XPT systems alternately, a review of patient outcomes generated over the past three months is recommended. Customers should not use the ADVIA Centaur XP / XPT and ADVIA Centaur CP Systems together to generate CA 19-9 results for patient monitoring. Serial patient monitoring can continue as long as the system is used independently.
  • 원인
    The advia centaur cp assay ca 19-9 does not meet the correlation with the ca 19-9 assay of the advia centaur / xp / xpt systems as mentioned in the instructions for use. advia centaur cp generates lower results for patient samples. correlation and bias between systems can be verified in customer notification. with quality control material and external quality assessment material, customers may observe a bias in which the results of the ca 19-9 advia centaur cp test are higher than the results of the ca 19-9 advia centaur / xp / xpt.
  • 조치
    Field Action Code CC 16-02 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: ADVIA CENTAUR CA 19-9 Technical name: ANTIGEN CA 19-9 Registration number ANVISA: 103...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC