Events

Fluorocell PLT 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Sysmex Europe GmbH 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
    Field Safety Notice
  • 날짜
    2017-08-28
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Due to the low plt f results from the above affected fluorocell plt f lots, sysmex europe gmbh has decided, as part of the preventive measure, to withdraw the mentioned reagents.   the individual cartridges of the above-mentioned reagent lots indicate a sinusoidal difference between platelet counts of plt i and plt f. the results of plt f are much lower than the results of plt i. in some cases, the warning "abnormal plt scattergram" was triggered. however, this warning is not triggered in all cases. too low plt f was associated with a false estimate of the platelet population in the plt-f irradiation diagram.   internal testing with fresh human blood samples showed a decrease in lateral fluorescence (sfl) for samples measured in the plt f channel, in cases where the affected fluorocell reagent lot was used plt. as a result, the plt f population was not adequately counted as plt, so plt f scores became false. this can be seen in the dark blue-colored proportion of the plt population (see figure 2). additionally, ipf diagnostic parameters (ipf%) and ipf # (ipf counting) were potentially affected.

Device

Fluorocell PLT

Manufacturer

Sysmex Europe GmbH