Events

ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD)(clinical chemistry analysers) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter Australia 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-2013-RN-01012-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-10-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01012-1
  • 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
    Beckman coulter has confirmed that some ise units can experience premature ise ref (reference) valve failure. premature valve failure can be detected by the presence of air bubbles in the ise ref solution tubing on the ise unit. if air bubbles are present, accuracy of the ise test results may be affected. affected results may be clinically significant (high or low) and may impact patient diagnosis and/or treatment.
  • 조치
    Beckman Coulter is providing users with instructions on how to inspect tubing for the presence of air bubbles. Where air bubbles are present, users are to contact Beckman Coulter for a replacement valve. Beckman Coulter is recommending consulting the laboratory director to determine the impact of this issue and if a retrospective review of prior results is necessary. As a preventative measure, Beckman Coulter is proving work around instructions for users to follow until a replacement ISE valve is implemented.

Device

ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry ...
  • 모델명 / 제조번호(시리얼번호)
    ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD)(clinical chemistry analysers)Part Numbers: MU3226 and MU7638All model numbers affectedARTG Number: 177999
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd