Events

iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips 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-00671-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00671-1
  • 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
    The ichemvelocity systems do not maintain the on-board strip stability claim of 10 days at 18-28 degrees celsius at 20-80% relative humidity (rh) as stated in the ichemvelocity product labelling. the on-board strip stability is affected by temperature and humidity in your laboratory. test results may be affected as indicated below:false low or false negative results: ketone, bloodfalse high or false positive results: bilirubin, urobilinogen, glucose, nitritefalse high results: leukocytesascorbic acid, protein and ph are not affected.
  • 조치
    Beckman Coulter is providing an updated stability guide and additional handling instructions to ensure the stability of the test strips. The manufacturer, Iris International, has determined that the Strip Provider Module is not maintaining the humidity levels associated with the original on-board strip stability claim and is urgently developing a corrective action. This action has been closed-out on 06/09/2016.

Device

iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips
  • 모델명 / 제조번호(시리얼번호)
    iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry StripsStrip part numbers 800-7204 and 800-7204-001
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd