Events

Avis De Sécurité sur QMS® Everolimus Immunoassay

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 Thermo Fisher Scientific.

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
    2016-10-24
  • 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
    On august 22, 2016 we sent you the below notice on the qms® everolimus immunoassay. since this letter was sent to you additional information has come to light regarding patient samples. originally in the “reason for field action” section we reported that “current patient samples are not in question.” thermo fisher wishes to update that statement to the following: “you may observe bias in patient samples ranging from -15.7% to +5.2% with an average bias of -5.6% when comparing your assay to the lc-ms reference method”. additionally, thermo fisher is also updating the “risk to health” section. the update clarifies that all ranges (sub-therapeutic, therapeutic, supra-therapeutic) may be affected by as much as 16%. .

Device

QMS® Everolimus Immunoassay

Manufacturer

Thermo Fisher Scientific