Events

BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Becton Dickinson 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-2013-RN-01315-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01315-1
  • 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
    Bd has determined that some db bactec fx instruments contain racks that may demonstrate variable indicator light intensities. specifically, the anonymous vial indicator lights, which should appear yellow, may instead appear green in colour. this has the potential to lead a user of the instrument to accidentally discard an anonymous vial or the readings associated with an anonymous vial, before an anonymous vial has completed protocol. the affected instruments continue to function properly and will not report an incorrect result.
  • 조치
    BD is providing a software update to correct the issue, which will be available in February 2014. As an interim measure, BD is providing users with work around instructions to follow until the software upgrade is completed.

Device

BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)
  • 모델명 / 제조번호(시리얼번호)
    BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)BD BACTED FX - Top UnitReference Number: 441385Serial Numbers: FT2899, FT2914, FT2951 & FT3077BD BACTEC FX - Bottom UnitReference Number: 441386Serial Numbers: FB1724 & FB1756
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd