Events

Avis De Sécurité sur Fluorocell PLT

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Sysmex Europe GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2017-08-28
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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