Events

Etest PIPTAZO PTC 256 (used for testing of Enterobacteria strains). 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-2015-RN-01171-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-12-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01171-1
  • 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
    It has been identified that isolates (enterobacteria strains) were tested with agar dilution and broth micro dilution reference method:using eucast breakpoints (mic< or =8: susceptible ; mic>16: resistant), etest pip/tazo showed a higher frequency of erroneous results, false susceptible results, when comparing to the referenced method (broth-micro dilution).The risk to patients as a result of the performance shift is the potential for reporting erroneous results for piperacillin/tazobactam; specifically false susceptible results. this risk may lead to medical intervention for the patient because the erroneous result could negatively influence the selection of antibiotic therapy.
  • 조치
    Biomerieux is advising users to discontinue use and discard any remaining units. Biomerieux is advising users to discuss any concerns regarding previously reported results with the Laboratory Medical Director. This action has been closed-out on 31/08/2016.

Device

Etest PIPTAZO PTC 256 (used for testing of Enterobacteria strains). An in vitro diagnostic medica...
  • 모델명 / 제조번호(시리얼번호)
    Etest PIPTAZO PTC 256 (used for testing of Enterobacteria strains). An in vitro diagnostic medical device (IVD) Catalogue Number: 412434, 521418 Multiple Lot Numbers affectedARTG Number: 187139
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd