Events

Avis De Sécurité sur MULTIGENT Creatinine (Enzymatic) assay

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 Sentinel CH Spa.

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
    2017-05-22
  • 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
    Sentinel has detected a performance issue with the reagent 1 component of the three impacted lots listed above. this issue may result in quality control values shifting out of acceptable range, which is not resolved by recalibration. only replacement of the impacted lots with a new lot resolves the issue. in addition, some customers have reported erratic patient results. the investigation has determined that this issue is isolated to the 3 impacted lots listed above. the corrective and preventive actions already in place will avoid any future recurrence. .

Device

MULTIGENT Creatinine (Enzymatic) assay
  • Modèle / numéro de série
    lots 60335Y600, 60382Y600 and lot 60334Y600
  • Manufacturer
    Sentinel CH Spa

Manufacturer

Sentinel CH Spa