Events

Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Strategy 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-2017-RN-00563-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-05-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00563-1
  • 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 nanostrong technologies has identified a quality issue with a single lot of the prosigna kit that may result in an error 35 of the prosigna assay due to high background. a specific failure mode has been observed at an elevated rate with prosigna kit lot 0100531017. this failure mode is pre-emptively identified by the embedded software, resulting in the output of an error by the system without the output of any test result. if this failure mode is experienced, a result for the sample would not have been obtained. if a test result was generated using this lot of kits, those results are not affected.
  • 조치
    Bio-Strategy is advising users to quarantine and place all unused kits from lot 0100531017 in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection and replacement of unused kits.

Device

Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD)Product Codes: NANPROSIGNA-002, NANPROSIGNA-003Lot Number: 0100531017ARTG Number: 226487
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd