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 BD 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 078 10 18 001
  • 사례 시작날짜
    2018-11-06
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13453
  • 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 , FDA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Bd has confirmed that a limited number of bd max™ systems were manufactured with purchased optical filters that have shown a potential to produce a false positive result for candida glabrata when processing samples positive for trichomonas vaginalis during testing with the bd max™ vaginal panel. if the bd max vaginal panel was successfully verified/validated using the contrived zeptometrix vaginal panel control panel, the risk of reporting a clinical false positive c.Glabrata result is low. the reported c. glabrata false positive results were all identified by customers when using the control material.

Device

BD MAX System
  • 모델명 / 제조번호(시리얼번호)
    Catalog No.: 441916 Multiple serial numbers of the affected device are provided in the attached FSN. ................................................................. FDA update codes: BD Max Instrument, Catalog Number 441916 441927 Serial Numbers: CTI1201-CTI1288 Catalog Number 8090369/443364, 44336409 Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 78387, 78182, 78832, 78905, 77062, 78856, 78352, 78903, 78667, 78665, 78928, 78986, 77108, 77543, 78615, 78481, 77373, 77707, 78927
  • 제품 설명
    IVD Test Reagent/Kits
  • Manufacturer
    BD

Manufacturer

BD