Events

Avis De Sécurité sur Sysmex CS-2000i, CS-2100i, CS-2500 and CS-5100 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 Products 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
  • 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 has confirmed that under very rare circumstances a false negative result may be reportable. the issue may only occur under the following conditions: • the initial result is falsely flagged with an antigen excess error that triggers an automatic remeasurement in a 1/19 dilution. and • the raw signal of the remeasurement is below the limit of blank (lob) of the method. under such conditions the low remeasurement raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low optical raw value. this raw value will be corrected by the dilution factor and can be deduced from calibration curve in a false low range. .

Device

Sysmex CS-2000i, CS-2100i, CS-2500 and CS-5100 System

Manufacturer

Siemens Healthcare Diagnostics Products GmbH
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    AMPMDRS