Events

Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. 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-01297-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01297-1
  • 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 received complaints regarding variability in recovery of qc and patient results with the dimension vista csa flex reagent cartridge lots 12300bb, 12318bb, and 13011bb. investigation by siemens confirms that the performance of these lots are atypical, and internal testing observed increases of >25% over several days for cyclosporine results in samples with csa concentrations below 125 ng/ml. daily qc checks can detect performance variations in this assay.
  • 조치
    Siemens is advising users to discontinue use and discard remaining inventory. Siemens recommends that the communication is reviewed by the Laboratory Director, a review of previously generated results is at the discretion of the laboratory.

Device

Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. An in vitro diagnostic medic...

Manufacturer

Siemens Ltd Diagnostics Division