Events

Sysmex CS-2100i and CS-5100 Automated blood coagulation analysers 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-00331-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00331-1
  • 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 manufacturer of the analyser, sysmex corporation, has informed siemens healthcare diagnostics about an issue potentially affecting the factor viii results. the factor viii chromogenic assay generates a curve from which a percentage result is calculated. the sysmex cs-2100i and cs-5100 automated blood coagulation analysers may generate an irregular curve that under certain circumstances could lead to an erroneously increased result with a factor viii chromogenic assay. the irregular curve is not flagged by the system.
  • 조치
    Siemens is advising their customers to run all Factor VIII Chromogenic assays in duplicate and confirm results in conjunction with the patient's clinical history. A software update is expected to be completed mid-2014 to correct the issue.

Device

Sysmex CS-2100i and CS-5100 Automated blood coagulation analysers
  • 모델명 / 제조번호(시리얼번호)
    Sysmex CS-2100i and CS-5100 Automated blood coagulation analysersCatalogue Numbers: 10488062 and 10708128ARTG Number: 179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division