Events

Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-00873-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00873-1
  • 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
    Siemens have identified that majority of current lots of this product are affected by reduced reagent stability after reconstitution.. affected lots were identified before release during regular quality control processes and became part of an extended testing program to verify reagent stability. there has been no impact on product performance within the reduced stability.
  • 조치
    Siemens is advising end users that reduced in use stability claims will be indicated on a ‘Pink Note’ included with the kits. This action has been closed-out on 31/05/2016.

Device

Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay)
  • 모델명 / 제조번호(시리얼번호)
    Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay)Affected lot numbers that have been supplied: 539267, 539267B, 539273, 539280, 539281, 539298, 539301, 539303A, 539305, 539306, 539309ARTG Number: 178501
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division