Events

Actin® Activated Cephaloplastin Reagent, 2 x 10 ml Pack - Registration 10345161140 - lot 557116 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 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
    1682
  • 날짜
    2015-09-01
  • 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
    Siemens confirmed for TTPa: variation greater than 3 seconds in the normal range and / or greater than 15% in the pathological range with the product at validity. It is possible that samples with values ​​close to the medical decision point may present deviations in the ranges: normal up to 4 seconds and pathological up to 33%. The upward trend of aPTT in most cases will be recognized by controls outside the designated range.
  • 원인
    Siemens healthcare diagnostics has confirmed internally that for lot 557116 the values ​​of the controls may be outside the designated ranges. in addition, it was observed that the results of the normal control presented values ​​with a tendency of high. this indicates change of product performance even within the validity.
  • 조치
    The company advises you to discontinue use and also discard any and all remaining material from the above-mentioned batch of Dade Actin Activated Cephaloplastin Reagent. This field action has the same content as the action communicated through alert 1569; the company's quality department identified the same problem in this lot, which generated this new field action.

Device

Actin® Activated Cephaloplastin Reagent, 2 x 10 ml Pack - Registration 10345161140 - lot 557116

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH