Events

BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Becton Dickinson 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
    Safety alert / Field Safety Notice
  • 날짜
    2018-04-26
  • 사례 출판 날짜
    2018-04-26
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/bd-vacutainer-edta-bd-vacutainer-lithium-heparin-tubes-risk-of-incorrect-results-for-lead-testing-or-other-assays-using-asv-methodology
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
    BD have published a Field Safety Notice to advise users to discontinue lead testing with affected devices when using assays with ASV methodology, known to be used within the Magellan LeadCare® testing systems, or any other assay employing ASV methodology.BD have identified that Thiuram, a chemical in the rubber tube stopper may release sulfur gases which bind to the lead particles in the blood sample making it difficult to detect the correct amount of lead in the sample and may give false low results when using ASV methodology, used in Magellan Diagnostics’ LeadCare® Testing Systems, and other assays.BD have undertaken a programme of testing to identify if any other assays are affected by the issue identified. To date no other assays have been noted to be affected. Revised instructions for use will be made available for users to download by the 8th May 2018.
  • 원인
    Manufactured by becton dickinson (bd) – due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using anodic stripping voltammetry (asv) methodology.
  • 조치
    Identify affected devices, which are listed in the manufacturer’s Field Safety Notice (FSN). Discontinue lead testing with affected devices when using assays with ASV methodology, known to be used within the Magellan LeadCare® testing systems, or any other assay employing ASV methodology. There is no requirement for customers to return affected devices to BD. Review previous lead test results which were performed using Magellan LeadCare® instrumentation or any other assay employing ASV methodology. Lead testing using Graphite furnace atomic absorption spectroscopy (GFAAS) coupled with ICP-MS are not affected by this issue and can be performed as normal with BD Vacutainer® EDTA and BD Vacutainer® Lithium Heparin tubes. If any adverse events occur relating to these products, please report these to MHRA via YellowCard or the relevant devolved administrations (Scotland, Wales and Northern Ireland).

Device

BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Becton Dickinson: BD Vacutainer® EDTA & BD Vacutainer® Lithium Heparin Tubes
  • Manufacturer
    Becton Dickinson

Manufacturer

Becton Dickinson