Events

Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) (An in vitro Diagnostic Medical Device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Leica Biosystems Melbourne 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-2014-RN-00476-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-04-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00476-1
  • 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
    Leica biosystems recently became aware that the affected product does not function as intended up to the expiry date on the product labelling. this was detected through stability monitoring carried out by leica biosystems. there is a link between the age of the product and staining intensity.
  • 조치
    Leica is requesting their customers to destroy any unused reagent from lot 24963 and confirm that the affected product is no longer in use.

Device

Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4) (An in vitro Diagnostic Medical Device (IVD)

Manufacturer

Leica Biosystems Melbourne Pty Ltd