Events

Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD) For use with the Access Family of Immunoassay Systems including the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter 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-2015-RN-00724-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00724-1
  • 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 access thyroglobulin reagent pack lots may generate falsely elevated results at concentrations <10 ng/ml. the estimated maximum magnitude of the potential error in the affected range is a shift of up to 0.36 ng/ml high at concentrations <10 ng/ml. acceptable total imprecision was observed at values of 10 ng/ml and higher.
  • 조치
    Beckman Coulter is requesting their customers to discard all Access Thyroglobulin reagent pack from the affected lots. Retesting should be carried out at the discretion of the laboratory director. This action has been closed-out on 26/08/2016.

Device

Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD) For use with the Ac...
  • 모델명 / 제조번호(시리얼번호)
    Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD)For use with the Access Family of Immunoassay Systems including the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.Product REF - 33860Lot Number:430969 431990 434727 522896 523251
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd