Events

Recall of CYTO TROL

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
    2002-09-24
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-cyto-trol-et-cyto-comp-cells-par-la-societe-beckman-coulter
  • 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
    Beckman Coulter has withdrawn lot 731972K (per 21.12.02) from the market for the in vitro diagnostic medical device called: CYTO TROL - reference 6604248 and lots 757239K (per 12.12.02); 757239K1 (per 12.12.02) and 757240K (per 06.03.03) of the in vitro diagnostic medical device called: CYTO COMP CELLS - reference 6607023 due to a lack of stability resulting in the appearance of excess debris in devices when used in flow cytometry. This excess of debris leads to the failure of optimizing the settings of the fluorescence compensations (error message "Comp fail").

Device

CYTO TROL
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER