Dimension Clinical Chemistry System and Dimension Vista System. 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-2017-RN-00002-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-04
  • 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 determined that some lots of ammonia (amm) reagent used on both the dimension® and dimension vista® systems do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay message. these lots may exhibit accuracy shifts for patient and/or quality control results; which may cause laboratories to recalibrate more frequently than the of 60-day claim in the instructions for use (ifu).
  • 조치
    Siemens is advising customers to discard affected lots and to use alternate lots instead. Customers are also to check the acceptability of the calibration and QC.

Device

  • 모델명 / 제조번호(시리얼번호)
    Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD).Dimension Clinical Chemistry SystemAssay: Ammonia AMMCatalogue No: DF119SMN: 10711991Lots: FB7152 (Exp 1/6/17), EB7180 (Exp 29/6/17), BA7194 (Exp 13/7/17), EA7223 (Exp 11/8/17), BA7250 (Exp 7/9/17)Dimension Vista SystemAssay: Ammonia AMMCatalogue No: K3119SMN: 10711992Lots: 16187BE (Exp 5/7/17), 16225BB (Exp 12/8/17), 16265AB (Exp 21/9/17)ARTG Number: 181689
  • Manufacturer

Manufacturer