Events

Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). 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-2017-RN-00137-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00137-1
  • 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
    On the abl800 series analysers, the sample type “cord blood” has been changed into the two sample types “cord blood arterial” and “cord blood venous". this change took place with software version 3.1 mr5. despite the selected sample type being correctly displayed on the abl800 series analyser itself, the analyser will transmit the less specific sample type "cord blood" to a his/lis or middleware system. the described error may in a worst-case scenario lead to minor foetal hypoxic stress not being immediately recognised if the clinician was to use data from the his/lis or middleware system to determine treatment. this may cause a minor delay of necessary treatment of the newborn infant.
  • 조치
    Radiometer is advising operators and clinicians using the "cord blood" sample results from a HIS/LIS or a middleware system to determine treatment to be aware that "arterial" or “venous" is not transmitted from the Analysers. Users are further advised that they will be notified when the new software fix is available for installation.

Device

Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic m...
  • 모델명 / 제조번호(시리얼번호)
    Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic medical device (IVD).All Serial Numbers connected to HIS/LIS or middleware Data Management systemARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd