Events

Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 In Vitro Technologies 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-2016-RN-00231-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00231-1
  • 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 has determined that the affected calibrator and controls require a reassignment which is 16% lower than the value established during the manufacture of this product. in vitro technologies is advising users to recalibrate the affected lots with the new calibrator values provided. the assay bias of 16% would result in a minimal change to low values. however the difference would be proportionately greater at higher values.
  • 조치
    In Vitro Technologies is providing users with revised target and range values to be used with the affected kits. The Director of Chemical Pathology should be consulted to determine the need for a review of results previously reported using this kit

Device

Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD)Item Numbers: TBSLK01610RI and TBSLK016ILot Numbers: 354992, 355769ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd