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 Radiometer Medical 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 040 11 12 001
  • 사례 시작날짜
    2014-01-30
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=5208
  • 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
    Radiometer recently became aware that some membranes may have enzyme residues on the outer membrane. upon replacement of the lactate membrane the enzyme residue may cause an initial negative bias on the reported lactate result. the bias decreases over the in-use time, and depending on the amount of residue it may take anything between hours and days for the bias to disappear. worst case the bias upon membrane replacement is -1.5 mmol/l at lactate levels over 7.0 mmol/l. this is most apparent when comparing results measured before and immediately after membrane replacement.

Device

Lactate membrane units
  • 모델명 / 제조번호(시리얼번호)
    The membrane units affected are: All lots of 942-066 When used on:ABL700 Series, and ABL800 Analyzers.
  • 제품 설명
    measuring, Lactate, membrane, Analyzers
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • 제조사 모회사 (2017)
    Danaher Corporation
  • 제조사 대표
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA