Events

ichem VELOCITY Urine Chemistry Strips. 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-2015-RN-01092-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01092-1
  • 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 become aware of a manufacturing defect where multiple strips with multiple missing pads were found inside the strip vial for the affected lot number. if the affected strips are used, it may result in quality control failures and potential false negative results for any or all analytes and erroneous ph results if affected strips are used to assay patient samples.
  • 조치
    Beckman Coulter is advising users to discard affected lots. Any affected lots will be replaced by unaffected product. Beckman Coulter is advising users to consult with the Laboratory Director to determine if a retrospective review of results is clinically warranted. This action has been closed-out on 18/08/2016.

Device

ichem VELOCITY Urine Chemistry Strips. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    ichem VELOCITY Urine Chemistry Strips. An in vitro diagnostic medical device (IVD). Reference Number: 800-7204Lot Number: 7204089B ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd