Events

BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device) 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-2018-RN-00072-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00072-1
  • 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 continuous surveillance on antimicrobial resistance, becton dickinson (bd) are aware of newly recognised or emerging strains that may yield an increased rate of false susceptibility in in vitro antimicrobial susceptibility test (ast) results to colistin.The labelling currently provided with the bd gram negative panels (nmic) panels indicates that colistin susceptibility can be determined. emerging strains have led to an increased number of resistant isolates reporting as susceptible when tested using the bd nmic panels with bd phoenix instrumentation.
  • 조치
    BD is advising users to perform an alternate method of testing prior to reporting susceptible colistin results. A resistant Phoenix colistin result does not require alternate testing. BD is not requesting that customers discard, return or discontinue use of the product. BD is also providing guidance for EpiCenter and BD Phoenix 100 &M50; instrument customers where rules can be created in the software to identify resistant isolates.

Device

BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)
  • 모델명 / 제조번호(시리얼번호)
    BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)Catalogue Number: 448788 Lot Numbers: ALLARTG Number 197287 (Becton Dickinson Pty Ltd - Antimicrobial susceptibility testing IVDs)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd