Events

CORTISOL IMMULITE, Kit for 100 tests, Registration 10345160665, lots 381, 382 and 383 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products Ltd 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
    1442
  • 날짜
    2014-10-17
  • 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 overseas manufacturer performed the problem analysis, evaluating all the inherent risks that generated the corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as without health risk, its severity being low and its probability of occurrence unlikely. The positive bias observed in cortisol values ​​may potentially lead to further investigation of the status of the adrenal gland. The overall health risk is negligible. Siemens does not recommend a previous review of the results for this reason.
  • 원인
    Siemens healthcare diagnostics has confirmed that the immulite / immulite 1000 cortisol kits 381, 382 and 383 demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. positive bias has also been observed in quality control materials and may result in values ​​outside the stated ranges.
  • 조치
    The company advises customers to stop using the product, segregate any remaining stock from the affected lots of CORTISOL IMMULITE with the intention of returning these products to Siemens and to keep the letter with the laboratory records.

Device

CORTISOL IMMULITE, Kit for 100 tests, Registration 10345160665, lots 381, 382 and 383

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products Ltd