Events

Avis De Sécurité sur EliA CCP 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 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
    2016-06-15
  • 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
    We informed you in fsn2016-02 that, when using elia ccp well in combination with elia igg conjugate, anti-ccp-signals are elevated for new conjugate lots. elia ccp well: (14-5515-01, 14-5515-41, 14-5515-03, 14-5515-10) elia igg conjugate: (83-1017-01, 83-1017-41, 83-1005-01, 83-1005-41, 83-1002-01, 83-1002-41 or 83-1018-01, 83-1018-41) solution of the problem: we will release new lots of elia ccp well that are optimized to the performance of currently available and future lots of elia igg conjugate. to ensure non-elevated assay performance these new elia ccp well lots must not be combined with old elia igg conjugate lots and old elia ccp positive control lots, as illustrated below. details on lot numbers can be found in table 1 and 2 in this field safety notice.

Device

EliA CCP Assay

Manufacturer

Thermo Fisher Scientific