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 Ortho-Clinical 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 103 07 18 002
  • 사례 시작날짜
    2019-01-09
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13721
  • 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: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169497
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    The purpose of this notification is to inform you that ortho clinical diagnostics determined that biased results may occur for specific vitros immunodiagnostic products (microwell assays) at biotin concentrations which are lower than indicated in the current instructions for use (ifu).

Device

VITROS MicroWell Assays
  • 모델명 / 제조번호(시리얼번호)
    VITROS Immunodiagnostic Products Folate Reagent Pack (10758750009237) : 1513266 VITROS Immunodiagnostic Products Free PSA Reagent Pack (10758750013517) : 6842845 VITROS Immunodiagnostic Products FSH Reagent Pack (10758750000302) : 1931922 VITROS Immunodiagnostic Products Prolactin Reagent Pack (10758750000111) : 1849793 VITROS Immunodiagnostic Products TSH Reagent Pack (10758750000227) : 1912997 ………………………. Swissmedic Update code: VITROS Immunodiagnostic Products NT-proBNP Reagent Pack (10758750002061) : 6802156 ………………………. FDA update codes: VITROS HBeAg Reagent, Cat. No 6801819 VITROS Anti-HBe Reagent Pack, Cat No. 6801816 All expired, in-date, and future lots released.
  • 제품 설명
    IVDs
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • 제조사 모회사 (2017)
    The Carlyle Group LP
  • 제조사 대표
    Samir Photographic Supplies Co. Ltd.
  • Source
    SFDA