Events

Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems. 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-2015-RN-01259-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-12-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01259-1
  • 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 received an increased number of customer complaints observed after s-cal calibration on the unicel dxh 800 and dxh 600 coulter cellular analysis systems, and the coulter lh 750 and lh 780 hematology systems. customers have reported a variety of issues during calibration including:- an increase in h&h; check messages- low mch recovery in xb- low mchc recovery in xbthese issues are not observed with all analysers and there is no impact to patient results.
  • 조치
    Beckman Coulter is advising users to monitor other quality control performance and adhere to the established maintenance schedule. Beckman Coulter is adjusting the SCAL values for lots starting 4782 and 113160400. This action has been closed-out on 16/05/2017.

Device

Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems.
  • 모델명 / 제조번호(시리얼번호)
    Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems. Catalogue Numbers: 624519, 179310 and 628026Multiple Kits and Vial Lot Numbers affectedAn in vitro diagnostic device (IVD)ARTG Number: 223050
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd