Events

Avis De Sécurité sur IMMULITE® 2000 IMMULITE® 2000 XPi

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 has confirmed that the immulite 2000®/immulite 2000 xpi® sex hormone binding globulin (shbg) adjustor lots 124 and 125 packed with reagent lots listed in table 1 do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8°c, as published in the instructions for use (ifu). reconstituted adjustors stored at 2-8°c after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. the reagent lots listed below can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg concentrations of 5 nmol/l to 170 nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not concentration dependent. .

Device

IMMULITE® 2000 IMMULITE® 2000 XPi
  • Modèle / numéro de série
    IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 357 2017/01/30 2016/03/08 2016/03/11 IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 358 2017/03/31 2016/05/04 2016/05/06 IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 360 2017/04/30 2016/06/13 2016/06/15
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

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