Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Remel Inc 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
    65184
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0793-2014
  • 사례 시작날짜
    2013-04-09
  • 사례 출판 날짜
    2014-01-21
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-01-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Susceptibility test discs, antimicrobial - Product Code JTN
  • 원인
    Cartridges may contain individual discs which were not impregnated with antibiotic.
  • 조치
    ThermoFisher Scientific sent a Medical Device Recall letter dated March 22, 2013, to affected customers. Letters dated April 9, 2013, were issued for the remaining three products. Customers were instructed to notify all personnel who need to be notified and review their inventory and discard any affected product. Customers were also instructed to return the attaced Medical Device Recall Response acknowleding the dispoasl of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 or 913-888-0939 (International). For questions regarding this recall call 913-895-4185.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 1192177, Exp. Exp. 31May2015
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: US including Puerto Rico.
  • 제품 설명
    Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. || Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
  • Manufacturer

Manufacturer