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 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 083 11 17 000
  • 사례 시작날짜
    2017-11-23
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11787
  • 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
    The cell-dyn ruby allows the display of parameter results in usa, international system of units (si), modified international system of units (si mod), unit set 1 or unit set 2 per user configuration. abbott has identified the following issue related to unit set selection for celldyn ruby analyzers using system software versions 2.2ml and lower: standard deviation (sd) values for select parameters (refer to table a) in the qc views only (qc-qcid data view and qc-levey jennings) will be incorrectly displayed when unit sets other than the usa unit are selected on the cell-dyn ruby. these units are incorrectly converted from usa units to other unit sets for display purposes. means, percent cv, and limit (upper and lower) information in qc views are correct. in addition, instrument flagging, alerts, and results are correct for all unit sets.

Device

CELL-DYN Ruby
  • 모델명 / 제조번호(시리얼번호)
    List Number: 08H67-01; 08H67-03 Serial Numbers: All serial numbers below 70594BG UDI: 00380740017170; 00380740099916
  • 제품 설명
    CELL-DYN Ruby
  • 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.
  • 제조사 대표
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA