Events

LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 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
    RC-2013-RN-00125-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00125-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has become aware that lifecycle for prenatal screening may generate an incorrect risk calculation with ivf (in vitro fertilisation) screening cases. the problem occurs if the user enters data incorrectly in combination with a specific series of events as described below:· the user initially enters the mother’s birth date (dob) incorrectly for an ivf case, and calculates the risk using the incorrect dob· the user recognises the dob entry error, corrects the error by entering the correct dob and recalculates the risk · lifecycle does not utilise the corrected dob, and recalculates the risk using the initial, incorrect dob · lifecycle generates an incorrect risk calculation for the ivf screening case.
  • 조치
    The LifeCycle issue can be corrected by either upgrading to LifeCycle software version v4.0 Rev2, or by implementing dedicated software Service Pack (LifeCycle Service Pack 12-03c) to resolve the problem. End users are recommended to choose one of the two options and the software upgrade will be provided free of charge.

Device

LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. An in vitro diagnosti...
  • 모델명 / 제조번호(시리얼번호)
    LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 5002-0020, 5014-0020
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer