Events

LifeCycle for Prenatal Screening software 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-2015-RN-00999-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-10-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00999-1
  • 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 issue was caused by an unintended rounding of the median equation factors that led to inadequate number of significant digits (decimals) in the default median equation. the equation was originally introduced in lifecycle version v4.0 rev4. due to the issue, the inhibin a mom level of an unaffected population was observed to be approximately half from what it should have been. this unintended rounding error was observed internally and no customer complaints have been received.
  • 조치
    Perkin Elmer is providing users with instructions to correct the error. Alternatively, Perkin Elmer can implement the correction at the affected site. This action has been closed-out on 19/08/2016.

Device

LifeCycle for Prenatal Screening software
  • 모델명 / 제조번호(시리얼번호)
    LifeCycle for Prenatal Screening softwareCatalogue Number: 5014-0020 Version Number: v4.0 Rev4ARTG Number: 216895
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer