Events

Recapper for the AutoMate 2500 Family. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter Australia 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-2017-RN-00748-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00748-1
  • 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
    Beckman coulter has identified there is a potential that a component on the recapper module did not have the required coating specified for that part.The coating on the recapper component helps to ensure both the longevity of the part, and help the gripper to release the parafilm so it properly seals to the tube. if there is an uncoated component on your recapper, this could lead to the tubes not being properly sealed. in the worst case scenario, this could cause sample cross contamination and subsequent misdiagnosis.
  • 조치
    Beckman Coulter will schedule a time to visit affected users to confirm whether the proper coating on the recapper component is present, and replace the component. In the interim, users are advised that no action is required on their part.

Device

Recapper for the AutoMate 2500 Family. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    Recapper for the AutoMate 2500 Family. An in vitro diagnostic medical device (IVD).ODL25250 AutoMate 2500ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd