Events

Avis De Sécurité sur BD CD56 PE-Cy™7 (CE-IVD)

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 Becton Dickinson France S.A.S..

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
    2015-07-17
  • 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
    Becton, dickinson and company (bd) has determined that the cd56 pe-cy7 reagent contains a low amount of hla-dr pe antibody. bd has confirmed that the concentration of the cd56 antibody in the pe-cy7 conjugate is sufficient to detect cd56 antigen on the targeted cells. the presence of hla-dr pe could result in the possibility of an unexpected staining pattern. therefore, we recommend that you examine your data files obtained using reagents from the affected lot for the possibility of additional staining due to the presence of hla-dr pe, which might or might not appear based upon the analysis method. .

Device

BD CD56 PE-Cy™7 (CE-IVD)
  • Modèle / numéro de série
    Lot Number 4300715 (expires 2015-10-31) Lot Number 4353883 (expires 2015-10-31)
  • Manufacturer
    Becton Dickinson France S.A.S.

Manufacturer

Becton Dickinson France S.A.S.