Events

Recall Or Safety Alert for Reagent BD FMC7 FITC, catalog number 332786, lots 4161883, 4217505, 4255539, 4281895, 4356888, 5034663, 5093768, 5138959, 5180754.

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Becton Dickinson & Company, BD Biosciences.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Date
    2015-12-28
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Cessation of the use of certain batches of the reagent for the B / T BD FMC7 FITC cell subtype, catalog number 332786, manufactured by Becton Dickinson & Company, BD Biosciences, USA, due to the functional degradation thereof.

Device

Reagent BD FMC7 FITC, catalog number 332786, lots 4161883, 4217505, 4255539, 4281895, 4356888, 50...

Manufacturer

Becton Dickinson & Company, BD Biosciences