Events

LifeCycle for Prenatal Screening software. 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-00843-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00843-1
  • 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 of an unexpected behaviour in how the lifecycle risk calculation engine (elipse) accepts and utilizes the ethnic factor given by the user. if the ethnic factor has been changed from a valid numeric value to "0" (zero) the case risk will not be calculated by applying the latest validated median equation as intended by the user.
  • 조치
    PerkinElmer is advising users to replace the default median equations supplied at installation with laboratory-specific ones and maintain the Marker Medians-form to ensure the Ethnic Factor values are greater than zero. PerkinElmer are recommending users update the software to version 4.0 rev 2. A review of past results should be made on a case by case bases as recommended by PerkinElmer.

Device

LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).Catalogue numbers: 5002-0020Software version: v2.1, v2.2, v3.0, v3.1, v3.2 (including all revisions)
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer