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 Siemens Healthcare 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 068 07 18 000
  • 사례 시작날짜
    2018-07-11
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12904
  • 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
    Siemens healthcare diagnostics has received customer complaints regarding dimension vista® loci® reaction vessels causing vessel pickup errors. supplier internal investigation has identified the potential for a loci reaction vessel to contain a small hole or indent on the top of the vessel. this may result in the vista system generating a “vessel pickup error” when the defective vessel is not successfully picked up by the vacuum system. the error is resolved when the defective vessel is removed from the system.

Device

Dimension Vista LOCI Reaction Vessels
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: KS855 Siemens Material Number: 10445212 Lot Number: All lots prior to lot NH3912618 First Shipment Date: 2018-05-10
  • 제품 설명
    IVD Test Reagent/Kits, Immunoassay
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • 제조사 모회사 (2017)
    Siemens Ag
  • 제조사 대표
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA