Events

LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD) 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-2013-RN-01284-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01284-1
  • 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
    Update: beckman coulter's investigation has shown that the lh cleaner and coulter clenz was the main contributor to the optical degradation issue.Complaints related to optical degradation have increased on the lh 750 and lh 780 haematology systems. customers have reported an increase in ls offset error messages during startup, background, control and/or patient analysis.The optical degradation may potentially cause a delay in reporting results for nucleated red blood cells, white blood cell differential and/or reticulocytes.Cbc panel results are available for reporting and are not affected by this issue.
  • 조치
    Update: Beckman Coulter is requesting their customers to discard the affected lot of LH Cleaner. Laboratories can discontinue the additional Clear Flow Cell and Extended Cleaning actions. Beckman Coulter is recommending users perform a Clear Flow Cell and Extended Cleaning and perform a routine shutdown at least daily. Beckman Coulter is investigating this issue further in order to provide a permanent fix.

Device

LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)LH 750 Haematology SystemPart Numbers 6605632 and A85570LH 780 Haematology System Part Numbers 723585 and A90728
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd