Events

Field Safety Notices about FMC7 FITC (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
    2015-12-17
  • 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
    The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%. the adverse effect on reagent performance is not expected to impact any data other than poorly staining donors already expressing at low levels.

Device

FMC7 FITC (CE-IVD)
  • Model / Serial
    Lot Number 4161883 (expires 08-31-2015) Lot Number 4217505 (expires 10-31-2015) Lot Number 4255539 (expires 10-31-2015) Lot Number 4281895 (expires 12-31-2015) Lot Number 4356888 (expires 03-31-2016) Lot Number 5034663 (expires 03-31-2016) Lot Number 5093768 (expires 06-30-2016) Lot Number 5138959 (expires 06-30-2016) Lot Number 5180754 (expires 08-31-2016)
  • Manufacturer
    Becton Dickinson France S.A.S.

Manufacturer

Becton Dickinson France S.A.S.