Events

Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determination of prothrombin time). 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-2013-RN-00151-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00151-1
  • 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 investigations have confirmed that with sysmex cs-2000i or sysmex cs-2100i systems the last (up to 4) measurements out of a thromborel s vial may be erroneously prolonged (longer pt sec, lowered % of norm, increased inr). this may occur if the reagent in the vial is nearly used up and has been placed on board of the sysmex cs-2000i/cs-2001i systems for more than 4 hours.
  • 조치
    End users are being advised to mix reagent carefully every 4 hours. Review of patient results should be carried out at the discretion of the laboratory director. Siemens representative will contact the affected customers as soon as a technical solution is available.

Device

Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determin...
  • 모델명 / 제조번호(시리얼번호)
    Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determination of prothrombin time). An in vitro diagnostic medical device (IVD)Siemens Catalogue & Material Numbers: OUHP295 / 10446442 & OUHP495 / 10446445Sysmex Japan Catalogue & Material Numbers: OUHP295J / 10469932 & OUHP495J / 10469933ARTG Numbers: 178501 & 179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division