Events

Recall of ProCOUNT kit (Progenitor Cell Enumeration Kit)

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by BECTON DICKINSON.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2001-05-30
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-du-kit-procount-numeration-de-cellules-cd34
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    Lots 21108, 21639, 22204 of the ProCOUNT kit (Progenitor Cell Enumeration Kit) - ref. 340498, from Becton Dickinson, are withdrawn from the market, at the request of the company, following a decrease in the fluorescence intensity of the CD45 PerCP reagent ("control reagent") present in the kit.

Device

ProCOUNT kit (Progenitor Cell Enumeration Kit)
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON