Events

PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an in vitro diagnostic medical device) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-00648-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-06-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00648-1
  • 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
    Siemens healthcare diagnostics has confirmed an overall average positive bias of approximately 20%-23% across the assay range relative to who 96/670 with the immulite systems psa assays. this positive bias is observed in patient values and the siemens tumor marker controls (tmco).
  • 조치
    Siemens are advising users to discontinue use and discard any remaining kits. Replacement kits will be available in July 2013. Siemens is recommending a lookback period of two months of previous test results. For results that were recorded as abnormal, please notify the treating physician. Actions by the clinician may be to reconsider a scheduled biopsy based on the test result taking into account the other factors that made biopsy a consideration.

Device

PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an ...
  • 모델명 / 제조번호(시리얼번호)
    PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an in vitro diagnostic medical device)Multiple Lot numbers affectedMultiple Catalogue numbers affectedAll kit lots released in February 2012.ARTG Number: 180971
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division