Events

ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device) 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-2018-RN-00090-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-01-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00090-1
  • 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
    Following a study conducted on etest polymyxin b with 180 clinical strains (pseudomonas aeruginosa, acinetobacter and enterobacteriaceae), an underestimation of mics has been observed for pseudomonas aeruginosa and acinetobacter species, compared to those obtained using the broth micro-dilution (bmd) reference method. this has led to false susceptible results when the etest polymyxin b results are interpreted using clsi breakpoints; there are no breakpoints for this drug in the eucast guidelines. as a consequence, etest polymyxin b (ref. 533400 & 533408) blister packaging can no longer be recommended for use with pseudomonas aeruginosa or acinetobacter strains.
  • 조치
    bioMérieux is advising customers to discontinue use of the ETEST Polymyxin B strips to determine the MICs for Pseudomonas aeruginosa or Acinetobacter species. Laboratories can continue to use ETEST Polymyxin B for Enterobacteriaceae species.

Device

ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)
  • 모델명 / 제조번호(시리얼번호)
    ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)POLYMYXIN B PO 1024 WW B30 Reference Number: 533400Batch Numbers: 1005807890, 100575830, 1005497750, 1005161530, 1004414690POLYMYXIN B PO 1024 WW B100Reference Number: 533408Batch Number: 1004530070ARTG Number: 187139 (Biomerieux Australia Pty Ltd - Antimicrobial susceptibility testing IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd