Events

Coagulation Analyzer 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Sysmex Corporation || Sysmex Corporation Kakogawa Factory 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
    I1702-60
  • 사례 연번
    2010DM-0005612
  • 날짜
    2017-02-20
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=101
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has confirmed that, in very rare circumstances, a false negative result for the innovance d-dimer assay may be reported by the referenced devices, as a result of an antigen overflow error that triggers an automatic re-reading of 1/19 and the unprocessed signal the reading is lower than the white limit method (lob), leading to alterations in the result.

Device

Coagulation Analyzer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The coagulation analyzers CS2000I / CS2100I are fully automated instruments for quantitative decoagulation tests by coagulometry, immunological and chromogenic. Continuous random access. Uses plasma samples for in-vitro diagnostic tests (IVD) of PT, APTT, TT, fibrinogen, D-Dimero, AT-III; PLG; PC and individual factors I to XIII. It is in an automated system that reports the values of the tests and communicates the results of the patient's clinicians. The reagents that are used with the SYMEX CS2000I / CS2100I equipment have their respective health records.
  • Manufacturer
    Sysmex Corporation || Sysmex Corporation Kakogawa Factory

Manufacturer

Sysmex Corporation || Sysmex Corporation Kakogawa Factory