Events

Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD) 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-2017-RN-00820-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-06-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00820-1
  • 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 determined that additional clarification for the blast suspect messages is necessary. in rare situations, the lh 750, lh 780, lh 500 and hmx analysers may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as the properties of blasts in certain samples. if these limitations are not clearly understood or are misinterpreted, in rare situations there could be a delay in the recognition, diagnosis and treatment of conditions associated with blasts in the peripheral blood.
  • 조치
    Users are asked to refer to the modified information for both the Suspect messages and Limitations sections for the Differential as contained in the Customer Letter.

Device

Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD)Coulter LH 750 AnalyserReference Numbers: 6605632, A85570, A68807 Coulter LH 780 AnalyserReference No: 723585, A90728, A68808 Coulter LH 500 AnalyserReference No: 178832, 178833, 178834, A91062, A90994 Coulter HmX CP AnalysersReference No: 6605522, 6605523, 6605524 Coulter HmX AL AnalysersReference No: 6605525, 6605526, 6605527, A85566, A85564 All software versionsARTG Number: 177999
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd