Events

Avis De Sécurité sur ADVIA® 560 Hematology System

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 Siemens Healthcare Diagnostics Inc..

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
  • 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
    Siemens healthcare diagnostics is conducting an urgent field safety notice for the advia 560 hematology system software. siemens has identified that software version 1.4.2133 does not trigger the following flags: · the w warning flag for detecting small sample volumes when using the international software configuration. if there is not enough sample volume of the patient’s blood when the sample is run, results may be lower than expected. this can occur if the required sample volume as defined in the advia 560 hematology system operator’s guide is not followed. · the g or l morphology flags for immature granulocytes (ig) and atypical lymphocytes (atyp), respectively. .

Device

ADVIA® 560 Hematology System

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    AMPMDRS