Events

ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare Pty Ltd 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-2015-RN-00739-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-08-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00739-1
  • 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 confirmed that urea nitrogen reagent kit lots listed and urea nitrogen concentrated reagent kit lots listed for use on advia 1200, 1650, 1800, 2400 and xpt chemistry systems demonstrate an increased incidence of calibration failures. results cannot be generated by the system when calibration fails. failed calibration may lead to a slight delay in results until a replacement or suitable material to perform the calibration verification is obtained. the risk to health is negligible.
  • 조치
    Siemens is advising users that if they experience this issue, to request unaffected replacement product. Siemens is not recommending a review of previously generated results. This action has been closed-out on 07/09/2016.

Device

ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnos...
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnostic medical device (IVD)Urea Nitrogen AssayCatalogue Number: 03040257Lot Numbers: 321973, 333872Expiry date: 2015-11Lot Number: 348126Expiry date: 2016-06Urea Nitrogen Concentrated AssayCatalogue Number: 06860558Lot Number: 321967 Expiry date: 2015-11Lot Number: 332365 Expiry date: 2016-03ARTG Number: 176642
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd