Events

Dimension and Dimension Vista Gentamicin (GENT) Flex reagent cartridge. 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-00363-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00363-1
  • 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 dimension gentamicin (gent) may exhibit inaccuracy for quality control (qc) and patient samples at the low end of the analytical measurement range. maximum negative bias of 100% and 48% were observed for patient samples at 0.9 mg/l [1.94 µmol/l] and 1.9 mg/l [4.1 µmol/l], respectively. patient samples at = 2.6 mg/l [5.62 µmol/l] did not show a bias. the bias is due to the calibration curve not showing separation between the level 1 and level 2 calibrators.
  • 조치
    Siemens is advising customers to inspect stock, discontinue use of and discard the affected Dimension and Dimension Vista GENT lots.

Device

Dimension and Dimension Vista Gentamicin (GENT) Flex reagent cartridge. An in vitro diagnostic me...
  • 모델명 / 제조번호(시리얼번호)
    Dimension and Dimension Vista Gentamicin (GENT) Flex reagent cartridge. An in vitro diagnostic medical device (IVD).Lot Numbers: EB8115, BB8159, FB8275,17135BC, 17150BF, 17159BD, 17178AC, 17269BD,17312BBSerial Numbers: 10444927, 10445120ARTG Number: 182220
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd