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 Diagnostica Stago 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 056 11 18 000
  • 사례 시작날짜
    2018-11-20
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13504
  • 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
    Stago has informed that several customers have reported shortened (t1-t2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds for sta-control la2 have been observed (this range is specified on the kit value sheet). the subsequent root cause investigations have found that the issue is due to a sensitivity decrease which occurs towards the end of the respective lot number's shelf life. we have found this to be related to the material used for manufacturing the stoppers used only for the buffer and solvent vials. according to guidelines of the isth ssc anti phospholipids syndrome, several tests should be performed to detect and confirm the presence of la. hence, previously released patient results should not need to be re-assessed. there have been no reports of injury in relation to this issue.

Device

STACLOT LA (REF. 00600).
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 251918 Expiry: 31 March 2019 Lot Number: 252751 Expiry: 30 September 2019
  • 제품 설명
    An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Diagnostica Stago

Manufacturer

Diagnostica Stago
  • 제조사 모회사 (2017)
    Stago International
  • 제조사 대표
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA