Events

Recall of Coulter Clenz®

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
    2005-10-13
  • 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-du-dmdiv-coulter-clenz-r-beckman-coulter-france-sa
  • 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
    On 11 October 2005, Beckman Coulter France SA withdrew from the market lots 30881 (per 20/05/2006), 30916 (per 08/06/2006), 30940 (per 28/06/2006) and 30941 (dated 28/06/2006) of the in vitro diagnostic medical device called Coulter Clenz® reference 8448222 following the detection of microbiological contamination on a limited number of containers resulting in high residual counts for platelets and platelets. Reticulocytes .. This device is a cleaning agent for automated hematology .. The company has directly notified the recipients of the offending lots by means of the message attached (13/10/2005) (24 KB) validated by the AFSSAPS .. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned. born.

Device

Coulter Clenz®
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER