Events

gabControl D-Dimer rapid test 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 gabmed GmbH 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
  • 날짜
    2016-10-18
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Due to weakly visible test lines in the said batches, it came to an increased amount of false-negative results. although the potential risk is considered to be minor with a test considered to be a pre diagnostic test, the product is being recalled from the european market by the gabmed gmbh as a precautionary measure to prevent false negative results. as the test is used as an aid in diagnosis, there is residual risk that additional .

Device

gabControl D-Dimer rapid test
  • 모델명 / 제조번호(시리얼번호)
    M09DD02 D-Dimer rapid test DIM16070008 04-2018 M09DD02 D-Dimer rapid test DIM16070007 04-2018 M09DD02 D-Dimer rapid test DIM16050005 04-2018 M09DD02 D-Dimer rapid test DIM16050004 04-2018 M09DD02 D-Dimer rapid test DIM16030006 03-2018 M09DD02 D-Dimer rapid test DIM16030001 02-2018 M09DD02 D-Dimer rapid test DIM16020004 12-2017 M09DD02 D-Dimer rapid test DIM16010006 12-2017 M09DD02 D-Dimer rapid test DIM16010003 11-2017 M09DD02 D-Dimer rapid test DIM16010002 12-2017 M09DD02 D-Dimer rapid test DIM15120003 11-2017 M09DD02 D-Dimer rapid test DIM15100003 10-2017 M09DD02 D-Dimer rapid test DIM15050008 05-2017 M09DD02 D-Dimer rapid test DIM15050007 05-2017 M09DD02 D-Dimer rapid test DIM15050006 05-2017 M09DD02 D-Dimer rapid test DDI150303 03-2017 M09DD02 D-Dimer rapid test DDI150302 03-2017 M09DD02 D-Dimer rapid test DDI141202 12-2016 M09DD02 D-Dimer rapid test DIM15060002 05-2017 M09DD02 D-Dimer rapid test DIM15060001 05-2017
  • Manufacturer
    gabmed GmbH

Manufacturer

gabmed GmbH
  • 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
    AMPMDRS