Events

OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device. 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-2018-RN-00291-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00291-1
  • 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
    An internal technical investigation by oxoid limited, part of thermo fisher scientific, has confirmed that the performance of antibiotic in thermoscientific oxoid ct1412b cpo30 cefpirome may decrease when stored over 2°c after 24 months. the product has a registered shelf life of 36 months. performance remains unaffected throughout shelf life when stored at -20°c to +2°c. continued use of lots older than 24 months if stored at 2-8°c, could result in false resistance reporting for cefpirome.
  • 조치
    Thermo Fisher is advising customers to inspect stock for affected product and remove them from further use. Users should destroy/discard all current and unused stock of the affected batches.

Device

OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device.
  • 모델명 / 제조번호(시리얼번호)
    OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device. Lot Numbers:1611705, 1693625ARTG Number: 208273Thermo Fisher Scientific Australia & New Zealand - Antimicrobial susceptibility testing IVDs
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand