Events

D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories 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-2014-RN-00280-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00280-1
  • 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 a rare occasion, the d-10 software might generate an extra result by duplicating the result from the previous sample and the sample id/injection # from the next sample. the duplicate is readily detectable when sorting the daily summary by the injection # and reviewing for duplication of the same sample id number. such duplication could potentially lead to discrepant sample results, which should not be reported.
  • 조치
    Bio-Rad are providing users with work around instructions to follow as an interim measure. Bio-Rad will release a permanent solution when available. This action has been clsoed-out on 18/02/2016.

Device

D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)Catalogue Number: 220-0220
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd