Events

Field Safety Notices about BD CD56 PE-Cy™7 (CE-IVD)

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Becton Dickinson France S.A.S..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-07-17
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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)

Manufacturer

Becton Dickinson France S.A.S.