Events

QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPC 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abacus ALS 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-2016-RN-00203-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00203-1
  • 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
    Investigations into complaints received have shown that in rare cases, the tests mentioned may give either falsely low crp resultsor the measurement flow is interrupted by the error message “faulty reagent addition”. falsely low crp results, in general, may providemisleading information for the diagnosis, therapy and monitoring of inflammatory disorders.The reported issue in a worst case scenario may cause a delay in starting the antibiotic treatment.
  • 조치
    The sponsor is advising users to immediately quarantine and discontinue use of kits from the affected lots. This action has been closed out on 08 Jun 2017.

Device

QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPC
  • 모델명 / 제조번호(시리얼번호)
    QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPCatalogue Number: 146521Production Lot: HX78Expiry Date: 24/11/2016QuikRead go wrCRP+HbCatalogue Number: 146255Production Lot: HX85Expiry Date: 31/01/2017ARTG Number: 206301
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd