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 097 02 18 000
  • 사례 시작날짜
    2018-02-19
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12174
  • 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
    Ventana medical systems, inc. (ventana, also known as roche tissue diagnostics (rtd) outside the us) has received increased customer complaints reporting leaking and sticking reagent dispensers. these reports are currently focused on horseradish peroxidase (hrp) dispensers (part of the iview, ultraview and optiview detection kits, as well as cintec plus cytology kit) and with hematoxylin ii. ventana has identified the cause of the issue, and is working to correct it. additionally, ventana has mandated specific requirements for same slide controls, detailed below, for customers with affected product in inventory.

Device

Hematoxylin II and Horseradish Peroxidase reagents
  • 모델명 / 제조번호(시리얼번호)
    Product Name : GMMI OptiView DAB IHC Detection Kit : 06396500001 ultraView DAB IHC Detection Kit : 05269806001 iView DAB IHC Detection Kit : 05266157001 ultraView SISH Detection Kit : 05271967001 ultraView SISH DNP Detection Kit US : 05572037001 CINtec PLUS Cytology Kit (CE-IVD) : 06889565001 CINtec PLUS Cytology Kit (Canada/Japan) : 06889549001 OptiView Amplification Kit : 06396518001 OptiView Amplification Kit (250 Test) : 06718663001 Hematoxylin II : 05277965001 ultraView SISH DNP Detection Kit : 05907136001 NEXES VEN IVIEW DAB DET KT JPN-US EXPORT : 05266084001 CINtec PLUS Cytology Kit (US-Export) : 06889549001 Multiple Lot numbers of the affected products are provided in attached FSN.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 제품 설명
    In vitro diagnostic devices
  • Manufacturer
    Roche Diagnostics

Manufacturer

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