Events

Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Immuno 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-2014-RN-00742-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-07-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00742-1
  • 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
    As a result of an internal investigation by trinity biotech, it has been determined that the symbol to denote 'harmful' has been omitted from the package insert. the information within the package insert regarding tha handling and disposal of the product is still correct. if the package insert and msds is followed correctly there is no risk to the end user when handling or disposing of the kits.
  • 조치
    Immuno is advising their customer that the product was supplied without the appropriate symbol to denote "Harmful". End users should be aware that all the information within the package insert is correct including handling and disposal instructions.

Device

Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical...
  • 모델명 / 제조번호(시리얼번호)
    Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical device (IVD).Product code: B1029-47Lot number: C091009Expiry date: 17 March 2015
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA