Events

Gene Amplification Reagent – Lynoamp BC. An in vitro diagnostic medical device. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 AA-Med 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-00399-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00399-1
  • 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
    The lynoamp bc is used for the detection of ck19 mrna in surgically removed regional lymph node in breast cancer (used for an aid to the diagnosis of lymph node metastasis in breast cancer). it was found by the manufacturer that a specific lot of lynoamp bc (lot number zs5011) showed an unexpected high positive rate.
  • 조치
    The customer has already been advised to dispose the affected unit and will be given replacement stock. This action has been closed-out on 26/05/2017.

Device

Gene Amplification Reagent – Lynoamp BC. An in vitro diagnostic medical device.
  • 모델명 / 제조번호(시리얼번호)
    Gene Amplification Reagent – Lynoamp BC. An in vitro diagnostic medical device.Product Code: BA895684Lot Number: ZS5011ARTG Number: 214482
  • Manufacturer
    AA-Med Pty Ltd

Manufacturer

AA-Med Pty Ltd
  • Source
    DHTGA