Events

NaCl, Enzyme Test and Cold Agglutinins ID Number: 50520 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-2014-RN-01000-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01000-1
  • 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
    During an internal investigation, the manufacturer determined that well number 3 of id card nacl, enzyme test and cold agglutinins of the affected lot may contain on a random basis a very small amount of monoclonal anti-e (anti-rh3).
  • 조치
    Bio-Rad is advising users to destroy any remaining affected units if unaffected lots of product are available. As an interim measure, if another lot is not immediately available it is possible to use lot 50520.93.09 with particular attention to the interpretation of positive results: - By manual method, do not use well 3 of the card. - On the automated method, if a positive result is obtained in well 3, use the manual method following the instruction above. This action has been closed-out on 03/06/2016.

Device

NaCl, Enzyme Test and Cold Agglutinins ID Number: 50520
  • 모델명 / 제조번호(시리얼번호)
    NaCl, Enzyme Test and Cold Agglutinins ID Number: 50520Reference Numbers: 005014 / 005015 / 005016 Batch number : 50520.93.09 with expiry 2016.01ARTG Number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd