Events

Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro 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-2012-RN-01048-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2012-11-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01048-1
  • 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 has received customer inquiries regarding correlation slope bias when comparing the dimension vista alp method to the dimension® alp method. siemens' internal investigation has confirmed that the activity of the dimension vistaalp cal, kc330, changes as the product ages and contributes to this correlation slope bias as well as accuracy shift. the magnitude of the accuracy shift is the same for qc and patient samples and does not exceed the allowable bias for the dimension vista alp assay. in order to ensure better correlation and accuracy, the shelf life for the dimension vista alp cal has been decreased from 12 months to 4 months.
  • 조치
    Siemens is providing work around instructions for users to implement.

Device

Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device...
  • 모델명 / 제조번호(시리얼번호)
    Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device (IVD)Catalogue Number: KC330Siemens Material Number: SMN 10445181Lot number recalled : 2AD052Lot numbers whose shelf life will be reduced: 2GD011 and higherARTG Number: 181688
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division