Events

Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE) 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-00334-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-03-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00334-1
  • 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 a complaint for under-recovery of patient samples with the dimension vista csa flex reagent cartridge when whole blood samples are run from small sample container (ssc). investigations by siemens have confirmed that csa, as well as csae, under-recovers by 18% to 44% when whole blood samples are run from ssc.
  • 조치
    Siemens is advising end users to cease using small Sample Containers when running whole blood samples with Dimension Vista CSA and CSAE assays. A review of previously reported results is recommended for cyclosprine samples run in Small Sample Containers. This action has been closed-out on 01/02/2016.

Device

Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE)
  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE) Flex Reagent CartridgeDimension Vista CSA:Catalogue Number: K4089Siemens Material Number: 10445139Lot Numbers: 13114BA, 13157BA, 13246BB, 13317BA, 14008BB & 14050BBDimension Vista CSAE:Catalogue Number: K4108Siemens Material Number: 10445142Lot Numbers: 13157BC & 13429BDARTG Number: 182779
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division