Events

EliA IgG Conjugate. An in vitro diagnostic medical device (IVD). 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-00599-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-05-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00599-1
  • 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
    Investigation of complaints received has concluded that when using elia ccp well (14-5515-01) in combination with elia igg conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01), anti-ccp-signals can be elevated for the listed conjugate lots.The positive bias of the elia ccp test will change a small percentage of test results from negative to equivocal and equivocal or high negative to low positive.Testing on clinical samples of both confirmed rheumatoid arthritis (ra) patient sera, healthy blood donors and other disease controls resulted in < 1% of the samples changing from negative to positive, according to current cut-off ranges (total study includes 472 samples). the results of the assay evaluation studies performed confirm the variance to be within current clinical performance, and it is concluded that the clinical impact of the observed bias is negligible.
  • 조치
    The sponsor is advising customers to stop using EliA CCP Well (14-5515-01) in combination with EliA IgG Conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01) of the affected lots as stated. The sponsor will provide unaffected EliA IgG conjugate lots as soon as they become available. This action has been closed-out on 15/02/2017.

Device

EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).EliA IgG Conjugate 50Article Number: 83-1017-01EliA IgG Conjugate 200Article Number: 83-1018-01EliA IgG ConjugateArticle Number: 83-1005-01 EliA IgG ConjugateArticle Number: 83-1002-01Multiple Lots and Kits affectedARTG Number: 229585
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd