Events

Synchron Enzyme Validator - an in vitro diagnostic medical device 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-2018-RN-00018-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00018-1
  • 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 that a supplemental product information notification is missing from enzyme validator kit lot m612600 due to the introduction of a new lot of traceable reference material in the manufacturing process.As a result, calibration with this lot may demonstrate differences in ast- or ggt patient and control values compared to calibration with previous lots. other enzyme assays are not affected.
  • 조치
    Beckman Coulter is advising affected customers to refer to the Supplemental Product Information provided with the Customer Letter for adjusting set points of AST- and GGT assays.

Device

Synchron Enzyme Validator - an in vitro diagnostic medical device
  • 모델명 / 제조번호(시리얼번호)
    Synchron Enzyme Validator - an in vitro diagnostic medical deviceReference Number: 441350Lot Number: M612600Expiry: 31/08/2018ARTG: 213974
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd