Events

ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing. 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-00470-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00470-1
  • 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
    A biomérieux investigation has confirmed a potential performance issue on strain categorization for streptococcus viridans group and streptococcus pneumoniae based on 2017 clsi and eucast breakpoints, which could lead to false susceptible result instead of resistant results on etest etp32 blister packaging when comparing to the broth-micro dilution (bmd) reference method.
  • 조치
    bioMérieux is advising customers who use the 2017 CLSI and 2017 EUCAST clinical guidelines that they can continue the use of ETEST ETP32 blister packaging except for Streptococci group including S. pneumoniae strains. bioMérieux is also advising that laboratories should identify any possible false Susceptible results from previously performed tests and analyse the related risks and determine appropriate actions if relevant.

Device

ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial sus...
  • 모델명 / 제조번호(시리얼번호)
    ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing.Reference Number: 531600 Multiple Lot NumbersARTG Number:187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd