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 Beckman Coulter 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 025 08 12 001
  • 사례 시작날짜
    2012-08-11
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2182
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Beckman coulter has determined that the ria ft3 lots listed above do not meet expiration date claims due to random instability of calibrator lot 1016 combined with the binding of the tracer close to the lower acceptance limit. • temperature excursion during transport and product storage may further contribute to this instability issue. patient sample results may be falsely elevated. • a falsely elevated ft3 result may result in a delay of diagnosis of secondary hypothyroidism, or an incorrect diagnosis and unnecessary treatment of t3 thyrotoxicosis.

Device

IVD, Free triiodothyronine (FT3) , radioimmunoassay
  • 모델명 / 제조번호(시리얼번호)
    Model: RIA FT3 Ref. number: IM1579, IM3320 Lot/batch no.: IM1579 - 120305C, 120305D, 120402C, 120402D, 120430C, 120430D, 120430E IM3320 - 120305D, 120402D, 120430D, 120430E (see attached For Expiration Dates)
  • 제품 설명
    IVD, Kit, radioimmunoassay
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter
  • 제조사 모회사 (2017)
    Danaher Corporation
  • 제조사 대표
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA