Events

AHG Control Cells 3%. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 bioCSL 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-01145-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01145-1
  • 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
    There is an issue with the ahg control cells not testing as expected. it is giving very weak positive reactions when it should be giving a strong reaction when validating antiglobulin tests.Ih production has determined that the product was not formulated correctly, as the trial pool of the anti-rh sensitising reagent and the bulk were not made to the same strength due to operator error. this has resulted in the bulk anti-rh sensitising reagent being made 10 x weaker than the trial pool. this weak batch was used for formulating the ahg control cells.
  • 조치
    The sponsor Seqirus is advising customers to inspect stock and quarantine all affected units prior to their return to the sponsor. The sponsor will arrange the replacement of the affected products or credit the account. This action has been clsoed-out on 29/08/2016.

Device

AHG Control Cells 3%. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    AHG Control Cells 3%. An in vitro diagnostic medical device (IVD)Item Number: 01901371Lot Number: 019075101Expiry Date: 18/12/2015ARTG Number: 224614
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd