Events

Avis De Sécurité sur Yumizen H500 CT (Closed Tube)

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 HORIBA ABX SAS.

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
    2017-06-20
  • 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
    Product development activities have shown that a defective positioning of the sampling needle could, in some instances, lead to the wearing of the rinsing header ring of the needle. this technical issue could generate an over estimation of platelets counting. this background is usually detected when a blank cycle is performed at the instrument start up (failed start up alarm). however, in other cases, the blank cycle does not detect the potential abnormal platelet background and could generate erroneous value of platelets counting.

Device

Yumizen H500 CT (Closed Tube)

Manufacturer

HORIBA ABX SAS