Events

ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD) (blood gas analyser) 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-2013-RN-01128-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01128-1
  • 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
    Radiometer has recently become aware of a potential issue of negative bias on sodium results if the abl90 is not on a horizontal table. when tilted by 10 degrees or more and idle for 30 -45 minutes the magnitude of the effect on sodium results is as large as 10 mm (7%) in the worst case.
  • 조치
    Radiometer is advising users to ensure that the ABL90 is placed on a horizontal platform/table. If the analyser is on a roll stand users must ensure that the support plate is aligned horizontally and locked in position. Radiometer will perform alignment of roll stands on request. A detection mechanism will be provided in an upgraded version of the analyser software to eliminate the possibility of error.

Device

ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD) (blood gas analyser)
  • 모델명 / 제조번호(시리얼번호)
    ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD) (blood gas analyser)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd