Events

Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Roche 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 ID
    MDA/2014/012
  • 사례 연번
    CON406356
  • 날짜
    2014-04-16
  • 사례 출판 날짜
    2014-04-16
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON406356?tabName=allTabs
  • 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
    The level sensing function of the cobas c502 laboratory analyser has not been activated for tests requiring manual reagent handling. the use of insufficient volumes of reagent may lead to a false negative result and a missed diagnosis, such as syphilis. it is possible to obtain ‘valid’ but inaccurate results when there is no reagent remaining in the roche cassette. since we issued a notice in february 2012 (mda/2012/004) the settings for level sensing have not been correctly encoded in some rec files, therefore level sensing may not have been correctly performed on cobas c502 analysers.
  • 조치
    Follow the required actions set out in the manufacturer’s Field Safety Notice (FSN). If you have used the affected combination of devices, consider the need to review previous results and whether to recall and retest patients. Action by: Laboratory managers Directors of pathology GUM clinics.

Device

Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser made by Hitachi, supplied by Roche. Multiple tests are affected, including syphilis (TPLA) test made by Sekisui. All reagents are supplied by Roche. The analyser can run assays that are: manufactured by Roche manufactured by third parties and supplied by Roche – ‘partnership assays’ (eg TPLA) Affected assays include those requiring manual handling that are listed in the Roche Field Safety Notice
  • Manufacturer
    Roche

Manufacturer

Roche