Events

Oxoid Antimicrobial Susceptibility Testing Discs TIM85(Timentin), CT0449B 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Thermo Fisher Scientific Australia & New Zealand 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-00094-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00094-1
  • 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
    Cartridges within the affected batch may contain some discs with a degraded or insufficient level of ingredient (clavulanic acid). a technical investigation confirmed that discs within this lot may have insufficient concentration of ticarcillin/clavulanic acid potentially resulting in below specification zones of inhibition. continued use of this lot could result in a false indication of resistance to timentin.
  • 조치
    Customers are advised to inspect stock on hand and and to remove from further use all affected units. On receipt of the Reply Form ThermoFisher will issue a credit note. This action has been closed-out on 24/05/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Discs TIM85(Timentin), CT0449B

Manufacturer

Thermo Fisher Scientific Australia & New Zealand