Events

HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Radiometer Pacific 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-00161-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-03-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00161-1
  • 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
    No specific limitations are given in the indications for use for the system. however, hemocue has become aware that there is a need to clarify that use of the hemocue wbc diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects, has not been fully evaluated by hemocue ab.Riskif incorrect results are obtained for these patient populations it could potentially lead to a delay in a dose modification and increased infection risk.Hemocue will be updating the instruction for use for the wbc diff system to include the above clarification.
  • 조치
    Radiometer will be providing updated instructions for use to provide clarification regarding the use of the HemoCue WBC Diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects.

Device

HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Numbers: 222568, 222701(Radiometer Pacific - Haematology full blood count IVDs)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd