Events

Avis De Sécurité sur Enzygnost Anti-HCV 4.0 on BEP 2000 / BEP 2000 Advance 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
  • Date
    2015-06-15
  • 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 have observed that in single cases the absorbance value obtained for the enzygnost® anti-hcv 4.0 control, positive on bep 2000 / bep 2000 advance system can be found lower than expected. the occurrence of this issue is triggered by an instrument liquid handling step (conjugate pipetting) in conjunction with enzygnost anti-hcv 4.0. as a precautionary measure we would like to inform you that an enhanced liquid parameter setting is now available for the enzygnost anti-hcv 4.0 method on bep 2000 / bep 2000 advance system. this enhanced setting has been verified internally and leads to a more robust assay performance. there is no change in the assay format, only a minor adjustment of the liquid parameter setting for the enzygnost anti-hcv 4.0 conjugate transfer step. .

Device

Enzygnost Anti-HCV 4.0 on BEP 2000 / BEP 2000 Advance System

Manufacturer

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