Events

PerkinEllmer LifeCycle for Prenatal Screening 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 PerkinElmer 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
    12921
  • 사례 시작날짜
    2012-12-03
  • 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: SciMed Ltd, Unit 2, 1 Tussock Lane, Ferrymead, Christchurch 8023
  • 원인
    Perkin elmer has become aware about lifecycle risk calculation problem that can potentially take place with assisted reproduction screening where an egg donor is involved. the change in calculated risk is dependent on the age difference between the mother and the egg donor. in the worst case, if the age of the mother is substantially higher than the egg donor's age. a true low risk value can be turned as high and thereby cause indirect harm because of possibility for an unnecessary medical intervention.
  • 조치
    Software to be upgraded

Device

PerkinEllmer LifeCycle for Prenatal Screening
  • 모델명 / 제조번호(시리얼번호)
    Model: 5002-0020, Affected: Software versions 3.0, 3.1, 3.2
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer