Events

Beckman Coulter UniCel system 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Beckman Coulter Inc 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
    21324
  • 사례 시작날짜
    2017-10-25
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • 원인
    In april 2017 the manufacturer issued an urgent medical device recall. as a follow up to this notification, the access br monitor instructions for use (ifu) will be updated. the updated ifu will reflect the 95th percentile upper reference limit (url) value for a healthy population, which was determined to be 23.5 u/ml. there is no change to the access br monitor assay.
  • 조치
    Manufacturer to issue advice regarding use

Device

Beckman Coulter UniCel system
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i systems.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc