Events

CORTISOL, LIAISON CORTISOL, record 10339840213, affected lot numbers: 244511X; 244521X; Risk class II 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 DiaSorin Ltda.; DiaSorin S.p.A. 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
    1709
  • 날짜
    2015-10-02
  • 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 registry holder, if the values ​​of the controls are outside the new ranges informed, the results need to be reviewed and informed to the clinician and according to the instructions for use of the product, patient results can only be interpreted in the answer to the table clinical and other diagnostic procedures.
  • 원인
    When the following bio-rad controls are used: lyphocheck immunoassay control, lot # 40310; liquicheck urine chemistry control, lot # 66700; lyphocheck quantitative urine control, lot no. 63350; in conjunction with the liaison cortisol kits for lots 244511x and 244521x, the values ​​and the theoretical ranges reported in the bio-rad leaflet are not appropriate. in these cases, the values ​​of the controls need to be changed in accordance with the attached technical note.
  • 조치
    Change control ranges if using the BIO-RAD controls of batches reported above. According to the company, the results already released need to be revised according to the results of the controls, if they were with the values ​​within the new ranges informed, no action is necessary if the results of the controls are with the results outside the new ranges the routine needs to be considered invalid by reviewing the sample values. Action code: FSN-29092015-1.

Device

CORTISOL, LIAISON CORTISOL, record 10339840213, affected lot numbers: 244511X; 244521X; Risk clas...

Manufacturer

DiaSorin Ltda.; DiaSorin S.p.A.