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 Roche 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 001 07 18 000
  • 사례 시작날짜
    2018-07-01
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12833
  • 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
    Roche has confirmed that sample material may potentially come in contact with the pipetting nozzle during operation. the possible presence of biological material on the nozzle has the potential to cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology. however, no complaints of false positives have been received from customers. cobas p 612 (63x) (lcp1) systems that use disposable filter tips are not affected by a potential contamination as the filter tips create a physical barrier preventing liquid exposure to the nozzle.

Device

cobas p 612 pre-analytical system (LCP1)
  • 모델명 / 제조번호(시리얼번호)
    GMMI / Part No: 07563116001 SW Version: All versions from 2.0 and higher
  • 제품 설명
    IVD, Specimen processing instrument IVD, automated
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics
  • 제조사 모회사 (2017)
    Roche Holding AG
  • 제조사 대표
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA