Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 DiaMed GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 068 06 13 000
  • 사례 시작날짜
    2013-06-16
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3751
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1 000 may be observed. after deep investigations, confirm that in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore, this issue might lead to a wrong result released to the host if all the 3 following conditions are met: 1. a result is returned as negative while the reaction is positive, dp, or requires a human interpretation . 2. this negative result is consistent with the global interpretation of the test. 3. the system is configured without the second reading function activated for all tests results.

Device

IVDs,blood transfusion instrumentation, IH-1000
  • 모델명 / 제조번호(시리얼번호)
    Product name: IH-1000 Product REF: 001000 IH-1000 software version: All version
  • 제품 설명
    IVDs, blood transfusion instrumentation
  • Manufacturer
    DiaMed GmbH

Manufacturer

DiaMed GmbH