Events

Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). 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-01298-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01298-1
  • 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
    It was determined through the course of a post-release product investigation that the control values on an affected lot of the freelite human kappa free kit require a reassignment which is 21% lower than the value established during the manufacture of the product. with the currently assigned values, if the controls are out of range (±20% of the concentration stated), then results of the run should not be accepted, which may lead to a delay in reporting results.
  • 조치
    In Vitro Technologies are providing users with revised values for the quality controls, which are to be used for the remainder of the shelf life of the Freelite Human Kappa Free Kit. This action has been closed out on 14 June 2017.

Device

Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). An...
  • 모델명 / 제조번호(시리얼번호)
    Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). An in vitro diagnostic medical device (IVD)Item Number: TBSLK016AULot Number: 358004ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd