Events

B.R.A.H.M.S Free BhCG Kryptor Kit. 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-2016-RN-00223-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00223-1
  • 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 has confirmed that the affected lots observe an overestimation of approximately 10% of free bhcg concentration in diluted samples or controls. undiluted samples and controls are not affected by the issue.The dilution of samples may lead to incorrect risk estimation for foetal chromosomal abnormalities. a patient may be considered at higher risk for trisomy 21 or at lower risk for trisomy 13/18.
  • 조치
    ThermoFisher Scientific is advising users that the affected lot can continue to be used for undiluted samples only. The affected lot should be discarded once the replacement product has been provided. This action has been closed-out on 09/05/2017

Device

B.R.A.H.M.S Free BhCG Kryptor Kit. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    B.R.A.H.M.S Free BhCG Kryptor Kit. An in vitro diagnostic medical device (IVD)Kit Reference Number: 809.075Lot Numbers: 09075 and 09073 ARTG Number: 199700
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific