Events

Alere HIV Combo 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 Alere 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
    2017-07-14
  • 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
    Patients may be exposed to unnecessary treatment if the instructions for use and other requirements for testing the algorithms are not followed closely, and if clinical measures are taken on the original p24 antigen-positive sample.   with this safety notice, we want to inform users that tests from the series below are more likely to detect the presence of p24 antigen, and to remind them of the recommendation in the package leaflet to confirm all initially positive results (indicating the presence of p24 antibodies and / or antigen) by the second method.

Device

Alere HIV Combo
  • 모델명 / 제조번호(시리얼번호)
    Alere HIV Combo 78169K100 7D2842 7D2843 7D2846 7D2847 7D2843SET 7D2843SET 78169K100E 78169K100A 78169K100C 78169K100B 78169K100R 78169K100S 79290K100 7D2843SET 79290K100R 79291K100 7D2843SET 79291K100R 79292K100 7D2843SET 79292K100R 79293K100 7D2842 7D2843 7D2843 7D2843SET 79293K100C 79293K100A 79293K100B 79293K100R AlertJ
  • Manufacturer
    Alere

Manufacturer

Alere
  • 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