Events

Alinity i Processing Module 에 대한 현장 안전성 서한

Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems에 따르면, 해당 현장 안전성 서한 는 Czechia 에서 Abbott 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
    Field Safety Notice
  • 사례 ID
    1358
  • 날짜
    2017-11-30
  • 사례 국가
    Czechia
  • 사례 출처
    MHSIDCCCDMIS
  • 사례 출처 URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • 비고 / 경고
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • 데이터 추가 비고

Device

Alinity i Processing Module
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 03R65-01 Serial Number: Ai01105 Ai01025 Ai01081 Ai01103 Ai01152 Ai01027 Ai01082 Ai01104 Ai01156 Ai01032 Ai01083 Ai01115 Ai01157 Ai01036 Ai01084 Ai01120 Ai01158 Ai01055 Ai01086 Ai01121 Ai01159 Ai01056 Ai01087 Ai01122 Ai01160 Ai01057 Ai01088 Ai01123 Ai01161 Ai01064 Ai01089 Ai01124 Ai01162 Ai01065 Ai01090 Ai01125 Ai01164 Ai01066 Ai01091 Ai01126 Ai01165 Ai01067 Ai01092 Ai01127 Ai01166 Ai01068 Ai01093 Ai01129 Ai01169 Ai01070 Ai01094 Ai01130 Ai01170 Ai01071 Ai01095 Ai01132 Ai01171 Ai01072 Ai01096 Ai01134 Ai01172 Ai01073 Ai01098 Ai01135 Ai01176 Ai01074 Ai01099 Ai01136 Ai01182 Ai01076 Ai01100 Ai01137 Ai01194 Ai01077 Ai01101 Ai01153 Ai01015 Ai01079
  • 제품 설명
    Diagnostic medical devices in vitro
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    MHSIDCCCDMIS