Recall of Flow-Count Fluorospheres reagent

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 BECKMAN COULTER.

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
    2007-06-11
  • Event Country
  • Event Source
    ANSM
  • Event Source URL
  • 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
    In agreement with Afssaps, the company Beckman Coulter, informed, on 07/06/2007, the users of Flow-Count Fluorosphères reagent used in flow cytometry for the determination of the absolute values ​​of the cell populations analyzed, the recall of a lot due to a lack of performance. The users of this device concerned by this defect in France have received the following letter (11/06/2007) (32 KB) The competent European authorities have been informed of this measure by the manufacturer.

Device

  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer

Manufacturer