ADVIA Centaur TnI-Ultra 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-2015-RN-00442-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-25
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 observed a system-to-system bias between the tni-ultra assay on the following systems:- advia centaur cp and - advia centaur- advia centaur xp- advia centaur xpt the advia centaur cp is generating lower results than the advia centaur/advia centaurxp/advia centaur xpt system. siemens is actively pursuing the cause of this issue.
  • 조치
    Siemens is providing end users with information to assist with the interpretation and release of troponin results. Siemens internal investigation has confirmed the clinical utility of the assay at the 99th percentile for healthy individuals (0.02 - 0.06 ng/mL (µg/L)) is not impacted by this issue.

Device

  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur TnI-UltraSiemens Material Numbers: 10317708 and 10317709Lots numbers ending in 088, 089, 090, 091, 093 and 094 and all future lots until issue is resolvedARTG number: 175197An in vitro diagnostic medical device (IVD)
  • Manufacturer

Manufacturer