Events

LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 DiaSorin Australia Pty Ltd 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-2016-RN-00942-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00942-1
  • 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
    Diasorin is issuing a correction for the liaison estradiol ii gen assay. due to the risk of recently identified cross-reactivity, the liaison estradiol ii gen assay should not be used to test patients being treated with fulvestrant (faslodex). cross reactivity of the drug fulvestrant may lead to falsely elevated test results in estradiol assays. this is due to the fact that fulvestrant has a similar chemical structure to estradiol and may cross-react with antibodies used in immunoassays. fulvestrant is indicated for the treatment of post-menopausal women with estrogen receptor positive recurrent stage iv breast cancer.
  • 조치
    DiaSorin is advising users to use an alternative method if measuring estradiol levels in patients being treated with fulvestrant, and advise clinicians that Fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. It is recommended laboratories consider the need to carry out a review of previously generated results. DiaSorin will be updating the Instructions for Use (IFU) to contain additional warnings. This action has been closed-out on 22/02/2017.

Device

LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). An in vi...
  • 모델명 / 제조번호(시리얼번호)
    LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD)Part Number: 310680All Lots affectedARTG Number: 201366
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd