Events

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Agilent Technologies 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-01330-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-10-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01330-1
  • 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
    Agilent has determined that a specific lot of flex monoclonal rabbit anti-human estrogen receptor clone ep1 has shown weak non-specific nuclear and cytoplasmic / stomal staining in known negative samples. in this affected lot some, but not all, breast cancer samples will show weak false-positive staining in some nuclei. this could result in a false-positive result in patient tissue and may not be detected by run controls.To date, agilent has not received any customer complaints regarding this issue.
  • 조치
    Agilent Technologies is advising users to discard affected Ready-to-Use GA084 vials from the affected lots. The vials should be discarded in accordance with the precautions in the Instructions For Use. Agilent will be providing affected users with replacement product in lieu of GA084. Laboratory Managers should review assay runs and patient results where the affected lots were used.

Device

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnost...
  • 모델명 / 제조번호(시리얼번호)
    FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use. An in vitro diagnostic medical device (IVD).Code Number: GA084Lot Number: 10125849Expiry: 31 March 2018ARTG Number: 183436 (Agilent Technologies Australia Pty Ltd - Immunohistology cell marker IVDs)
  • Manufacturer
    Agilent Technologies Australia Pty Ltd

Manufacturer

Agilent Technologies Australia Pty Ltd