Events

ID-Papain Assay. An in vitro diagnostic medical device (IVD) 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-2016-RN-00492-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00492-1
  • 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
    Following customer complaints, bio-rad has been able to confirm that the affected lots show a decrease in enzymatic activity, leading to false negative or false positive results. bio-rad is recalling the lots identified. this recall is being conducted as a precautionary measure.A risk assessment has been carried out and revealed that difficulty in interpretation of the results involving identification, auto-control and cross-matching in the enzyme technique may be experienced which may result in a delay in transfusion.
  • 조치
    Bio-Rad is advising customers to destroy remaining units of the affected lots, and is recommending using ID-Diluent as an alternative. This action has been closed-out on 03/02/2017.

Device

ID-Papain Assay. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    ID-Papain Assay. An in vitro diagnostic medical device (IVD)Catalogue Number: 005510Lot Numbers: 06311.53.1 (Expiry date 25/04/2016)06311.54.1 (Expiry date 09/05/2016)06311.55.1 (Expiry date 23/05/2016)ARTG Number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd