Events

Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). 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-2014-RN-00159-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00159-1
  • 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
    Biomérieux has identified that the affected etest strips do not give the correct minimum inhibitory concentration (mic) for some quality control strains, with the mic results out of range (high) according to the mic specification described in the quality control procedure.The mic results conformed at the time of batch release however investigations have confirmed this issue appears over time, leading to a performance issue by overestimating the mic.
  • 조치
    bioMerieux is advising users to discontinue use and destroy affected stock. Replacement kits will be provided once a new batch is available.

Device

Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). An in vitro diagn...
  • 모델명 / 제조번호(시리얼번호)
    Etest Ertapenem Foam and Single Blister Packs (antibiotic susceptibility test). An in vitro diagnostic medical device (IVD)Product Reference Number:531618Lot Number: 1002054430Reference /Lot Number inside packaging: 51103168, 1001897090Product Reference Number: 531610Lot Number: 1000853690, 1001960650Reference /Lot Number inside packaging: 51103610, 1001895910, 51103160, 1001895910Product Reference Number: 412332Lot Number: 1002110560, 1002389880ARTG Number: 187139
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd