Events

Siemens Immulite 2000/ Immulite 2000 xPi IGF-1 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens Healthcare Diagnostics Products Limited 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
    13811
  • 사례 시작날짜
    2012-11-19
  • 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, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • 원인
    The manufacturer has confirmed a positive shift in patient medians of approximately 20% with the igf-1 assay. siemens has determined that an initial positive shift of approximately 15% occcurred with immuliate 2000/ immulite 2000 xpi and an additiional positive shift of approximately 5% was observed with immulite 2000/ immulite 2000 xpi leading to the total positive shift of approximately 20%., two potential health risks:, 1. could mask uncontrolled acromegaly and thus affect patient treatment., 2. could lead to an under estimation of hgh deficiency in children with borderline hgh deficiency and potentially result in missed or delayed opportunity to treat with hgh supplement.
  • 조치
    Manufacturer to issue advice regarding use

Device

Siemens Immulite 2000/ Immulite 2000 xPi IGF-1

Manufacturer

Siemens Healthcare Diagnostics Products Limited