Events

Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Life Technologies Australia 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-2018-RN-00125-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00125-1
  • 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
    Life technologies has become aware of a performance issue where the specific lots of foetal haemoglobin monoclonal antibody are displaying high or unusually bright background which could potentially lead to erroneous(false positive) results.
  • 조치
    Life Technologies is advising users to discard any remaining product of the affected lot. A product hold has been placed on future stock, and a credit will be provided for all affected stock. A review of previously generated test results should be performed at the discretion of the laboratory Director.

Device

Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. An in vitro diagnostic medical device (IVD)Catalogue Number: MHFH01Lot Number: 1626670DExpiry Date: 30/04/2018ARTG Number: 212744 - (Life Technologies Australia - Haemoglobin IVD)
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd