Events

iQ200 Series Urine Microscopy Analysers 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter 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-2018-RN-00225-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-03-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00225-1
  • 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
    Beckman coulter has determined that there is a potential for under-reporting casts. this can occur if per high-power field (/hpf) units of measurement for casts are selected in the iq200 software, but the abnormal threshold and/or grading format is set up based on reporting “per low-power field (/lpf)” or “per microliter (/µl). this may occur during initial method validation or if settings are altered after the initial validation.
  • 조치
    Beckman Coulter is advising they will contact users to schedule a site visit to verify the reporting units of measurement for casts for their laboratory within 90 days of this recall initiation.

Device

iQ200 Series Urine Microscopy Analysers

Manufacturer

Beckman Coulter Australia Pty Ltd