Oxoid Antimicrobial Susceptibility Testing Disc NOR10 (Norfloxacin) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Thermo Fisher Scientific 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2013-02-22
  • 사례 출판 날짜
    2013-02-22
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: thermo fisher scientific oxoid antimicrobial susceptibility testing disc nor10 (norfloxacin) medical device manufacturer, thermo fisher scientific issued a medical device safety alert concerning oxoid antimicrobial susceptibility testing disc nor10 (norfloxacin) with model number ct0434b and lot number 1192177. according to the manufacturer, a technical investigation has indicated that cartridges of this lot of oxoid antimicrobial susceptibility testing disc nor10 (norfloxacin), may contain individual discs that are not impregnated with antibiotic. continued use of this lot could result in false indication of resistance to norfloxacin. the manufacturer advised the affected customers to: stop using this lot; destroy any remaining stock; review results reported using this lot; and consider retesting and/or seek appropriate expert advice. the manufacturer will also issue a product replacement. furthermore, the manufacturer and the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 february 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc NOR10 (Norfloxacin)
  • Manufacturer

Manufacturer