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 Bio-Rad Medical Diagnostics 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 063 07 17 000
  • 사례 시작날짜
    2017-07-17
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11308
  • 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
    It has come to our notice that for product id-papain, mal n° 005510, shows double population reactions when the auto-control is performed in papain one stage technique. it has been observed internally that in the last two weeks before expiry, the lots of papain mentioned above may not destroy these antigens as expected. there is no patient risk associated with this issue. the use of id-papain for compatibility testing and for the detection of antigens normally detected in the id-papain test is not impacted by this phenomenon and the papain can be used for this purpose.

Device

ID-Papain
  • 모델명 / 제조번호(시리얼번호)
    Double population reaction Mat. n° : 005510 Loss of enzyme activity Mat. n° : 005510 Lot No IHD : 06311 961, 06311 97 1, 06311 991, 06311 02 1 Lot No SAP : 121302961, 124782971, 141517991, 145832021 Expiry Date : 03.07.2017, 17.07.2017, 31.07.2017, 14.08.2017
  • 제품 설명
    Immunohematology, ID-Papain
  • Manufacturer
    Bio-Rad Medical Diagnostics

Manufacturer

Bio-Rad Medical Diagnostics