Events

RIA Coat-A-Count Androstenedione 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-2014-RN-00624-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00624-1
  • 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 received complaints regarding the coat-a-count direct androstenedione assay demonstrating a higher frequency of results >10 ng/ml (>25 nmol/l) compared to alternate platforms. through internal investigation siemens has determined that there is a potential of cross-reactivity in circulating physiological serum levels up to 8.82% detected with spironolactone and its two metabolites, canrenone and 7a-thiomethyl spironolactone with the ria cac direct androstenedione assay. the degree of cross-reactivity is dependent on the circulating dose in the patients’ serum.
  • 조치
    Siemens is advising pathology laboratories that the assay should not be used on patients being treated with spironolactone due to cross reactivity. These patients should be tested using an alternative method. A look back using another test method may be required if a patient has been administered spironolactone.

Device

RIA Coat-A-Count Androstenedione
  • 모델명 / 제조번호(시리얼번호)
    RIA Coat-A-Count AndrostenedioneCatalogue Number: TKAN1Siemens Material Number: 10381049Lot Numbers: 587 and aboveARTG Number: 210100
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division