Events

Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Thermo Fisher Scientific 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-00155-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00155-1
  • 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
    Thermo fisher scientific would like to inform that the use of calibrator brahms free beta-hcg kryptor cal may result in a decreased free beta-hcg concentration for brahms gm kryptor qc as well as for patient samples by approximately 4%. this may lead to incorrect risk estimation of chromosomal anomaly of the foetus.
  • 조치
    Thermo Fisher Scientific is advising users to stop use of the affected lot number. The affected lot will be replaces by a previous calibrator which may have a shorter expiry date. Thermo Fisher is recommending that results generated with the affected calibrator are re-evaluated in the context of other laboratory and clinical parameters and retest if required.

Device

Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD)Lot Number: 09045Expiry Date: 16 October 2014Kit Reference Number: CDB80991
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific