Events

HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD) for the quantitative detection of blood glucose) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 HemoCue 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-00279-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-03-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00279-1
  • 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
    During extended investigations on neonates it was confirmed that hemocue glucose 201 rt and hemocue glucose 201 dm rt perform according to specifications in all neonatal settings except neonatal intensive care. critically ill neonates in intensive care settings often have immature metabolism in combination with complex treatment. this setting has not been fully evaluated for hemocue glucose 201 rt and glucose 201 dm rt. incorrect readings may lead to indirect harm to patients such as misdiagnosis or inappropriate treatment. therefore the following text will be added to the intended use: "the system should not be used on critically ill neonates in neonatal intensive care settings".
  • 조치
    HemoCue is enclosing adhesive labels with the updated intended use along with the customer letters so that end users can use this to cover the current intended use in the Operating Manual, Technical Specifications etc.

Device

HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD)...
  • 모델명 / 제조번호(시리얼번호)
    HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD) for the quantitative detection of blood glucose)
  • Manufacturer
    HemoCue Australia Pty Ltd

Manufacturer

HemoCue Australia Pty Ltd
  • Source
    DHTGA