Events

Dimension Vista System - Blood Urea Nitrogen (BUN) Flex 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens Healthcare Diagnostics Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    20244
  • 사례 시작날짜
    2016-06-09
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, 55 Hugo Johnston Drive, Penrose, Auckland
  • 원인
    In february 2016, siemens healthcare diagnostics issued field corrective action letter vc 16-01, informing customers of well-to-well accuracy shifts for specific lots of dimension vista bun causing inaccurate patient and/or quality control results. at that time, preliminary investigation demonstrated loss of enzymatic activity of the gldh reagent wells made from a specific mold/cavity. they have since confirmed complaints on additional vista bun flex cartridge lots, suggesting an additional cause of reduced gldh activity.
  • 조치
    Product to be exchanged

Device

Dimension Vista System - Blood Urea Nitrogen (BUN) Flex
  • 모델명 / 제조번호(시리얼번호)
    Model: K1021, Affected: 16004AB, 16033AC, 16034AA, 16048AA, 16055AA,16055AB, 16062AA,16062AB
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc