Events

Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic medical device (IVD) 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-00843-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00843-1
  • 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 healthcare diagnostics has confirmed a carry-over risk on sysmex cs systems due to the applications using ca-clean i (964-0631-3) for sample probe rinse. under certain circumstances, the carry-over might impact results for factor v with innovin, factor xii with dade actin fsl, berichrom f xiii, innovance d-dimer assays. in case of innovance d-dimer, only frozen samples are concerned by a potential carry-over. no impact by carry-over was observed with innovance d-dimer when using fresh normal plasma or control plasma.
  • 조치
    Siemens Healthcare Diagnostics is advising the user to run all affected above mentioned test applications (Protein C with Protein C Reagent, Protein S with Protein S Ac Reagent and Factor V Leiden with ProC Global Reagent) together in a “Batch Mode” and perform an extra prime and rinse step at the end of the batch. Siemens Healthcare Diagnostics is working on a solution to fix the issue and will communicate when a solution is available. Siemens does not recommend a look back of previously generated results since the coagulation status changes over the time, and does recommend that this communication is reviewed with the laboratory medical director.

Device

Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic me...
  • 모델명 / 제조번호(시리얼번호)
    Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 10488064, 10488062, 10709128Affected Applications: Protein C with Protein C Reagent (OQYG11), Protein S with Protein S Ac Reagent (OPAP03) and Factor V Leiden with ProC Global Reagent (OQLS13)ARTG number:179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division