Events

BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Biomerieux 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-00794-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00794-1
  • 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
    Biomérieux has become aware of a crimp defect associated with the bact/alert bpn culture bottles. an anomaly was identified during the manufacturing process that may lead to having excess material at the neck of the bottle. this material may separate from the crimp exposing a sharp edge or causing a minor cut hazard.
  • 조치
    Customers are requested to: - Confirm this letter has been distributed to and reviewed by all appropriate personnel within the organisation. - Review inventory of BacT/ALERT BPN bottles for Lot Number 1048256 and discard all affected bottles from this lot. Please store this letter with your bioMerieux instrument documentation.

Device

BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD)Reference Number: 279045Lot Number: 1048256ARTG Number: 194228
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd