Events

ID-LISS/Coombs Cards. 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-2015-RN-00314-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00314-1
  • 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
    Unexpected reactions may rise in the 6th well of lot 50531.95.14 (exp. date 30/06/2016) product id: id-liss coombs cards reference 004017v (24 x 12 id-cards). investigations have identified that a high level of 'broken gel' during a certain time period during filling and only a very limited quantity of id-cards are affected by this phenomenon of unexpected reaction in the 6th well.
  • 조치
    To limit unexpected reactions, customers are asked to stop using the affected boxes (number between 5-1156-288 and 5-1156-318) and to destroy the remaining stock locally. Replacement unaffected stock will be sent.

Device

ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    ID-LISS/Coombs Cards. An in vitro diagnostic medical device (IVD)Ref: 004017VLot Number: 50531.95.14 (Exp 30.06.2016)Affected Box numbers: 5-1156-288 to 5-1156-318ARTG number: 217697
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd