Events

ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD). LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, and DiaClon Type + Screen 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories 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-2018-RN-00318-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00318-1
  • 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
    Bio-rad laboratories have been able to confirm an increased level of antibody of undetermined specificity (aus) when using some reagents of the id-system intended for irregular antibody screening and identification.
  • 조치
    BioRad is advising that the capacity of impacted lots of ID-Cards to detect and identify clinically significant antibodies is not affected by this issue. For that reason users may continue to use these products for their intended purpose. In the event users experience an AUS level impacting the ability to render final results, users should consider using an alternative method such as the tube method to verify results.

Device

ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro d...
  • 모델명 / 제조번호(시리얼번호)
    ID-Cards for Indirect Antiglobulin Testing associated with Reagent Red Blood Cells. An in vitro diagnostic medical device (IVD). LISS/Coombs, Coombs Anti-IgG, DiaScreen, LISS/Coombs + Enzyme Test, and DiaClon Type + ScreenProduct ID Numbers: 50531, 50540, 50571, 50581,50682Multiple Catalogue and Lot NumbersARTG Number: 212527(Bio-Rad Laboratories - Multiple blood grouping and typing IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd