Events

ADVIA Chemistry Systems - Urea Nitrogen (UN). 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-2018-RN-00303-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00303-1
  • 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 the urea nitrogen reagent kit lots 408143 and 418290 for use on advia 1800, 2400 and xpt chemistry systems are failing to perform as intended due to microbial contamination of a bulk reagent during the manufacturing process. this may demonstrate as an increased incidence of calibration failures. results cannot be generated by the system when calibration fails.If calibration passes, there is a potential for falsely elevated patient and quality control results.Internal testing has also shown that for the affected lots, results have the potential to be falsely increased by approximately 10 mg/dl (3.57 mmol/l) across the analytical range. quality controls may not always detect the elevated results.
  • 조치
    Siemens is advising customers to discontinue use of and discard affected kit lots. A replacement for discarded units will be provided.

Device

ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD) Catalogue Number: 03040257Lot Numbers: 408143, 418290Expiry (both lots): 28/06/2018ARTG Number: 176642Siemens Healthcare - Clinical chemistry substrate IVDs
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd