Events

Roche Elecsys Estradiol 11 and 111 Assays 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 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
    19811
  • 사례 시작날짜
    2016-03-01
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 원인
    If the estradiol status of postmenopausal women under treatment with fulvestrant is tested with elecsys estradiol ii or elecsys estradiol iii assays, an interference leading to falsely increased results of estradiol due to the drug may occur. subsequently the incorrect level of estradiol may lead to misinterpretations of the hormone status and the use of fulvestrant may be altered. in addition the efficiency of anti-estrogen treatment might be underestimated. a medical risk for postmenopausal women under fulvestrant treatment cannot be excluded.
  • 조치
    Product to be destroyed

Device

Roche Elecsys Estradiol 11 and 111 Assays
  • 모델명 / 제조번호(시리얼번호)
    Model: 03000079190 and 06656021190, Affected: all lot numbers
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479