Events

Field Safety Notices about Fluorocell PLT

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Sysmex Europe GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-08-28
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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