Events

ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Oxoid Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 연번
    MDA/2017/034
  • 날짜
    2017-11-23
  • 사례 출판 날짜
    2017-11-23
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/thermoscientifictm-oxoidtm-caz10-ceftazidime-ct1629b-antimicrobial-susceptibility-test-disc-potential-for-false-resistance-results-if-stored-at-the-wrong-temperature
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Manufactured by oxoid ltd (thermofisher scientific) – antibiotic (ceftazidime) concentration may decrease over time if test disc is stored between 2°c and 8°c: only specific lots are affected (mda/2017/034).
  • 조치
    Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice (FSN) and that they understand the problem and the actions to be taken. Destroy all affected lots (listed in the FSN) and contact Thermo-Fisher customer services / local distributor for replacements. Discs that have been stored between -20°C and 2°C remain unaffected for the entire shelf life (36 months). If concerns exist after repeat testing, alternative methods of establishing ceftazidime susceptibility should be used. As part of your review processes, report any incorrect results to MHRA via Yellow Card or the relevant devolved administration.

Device

ThermoScientificTM OxoidTM CAZ10 ceftazidime, CT1629B antimicrobial susceptibility test disc
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Oxoid Ltd

Manufacturer

Oxoid Ltd
  • 제조사 주소
    Martyn Rogers Thermofisher Scientific Wade Road Basingstoke RG24 8PW Telephone: 01256 694 245martyn.rogers@thermofisher.com
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    MHRA