Events

Recall of ACCESS® AFP

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
    2004-10-07
  • 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-access-afp-de-par-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
    The company Beckman Coulter withdraws from the market batches 415515 (per.30.09.05), 416251 and 416781 (per 31.10.05) of the in vitro diagnostic medical device called ACCESS® AFP - reference 33210, following the formation of a precipitates blocking agents present in the reagent, which may result in undervalued quality control results, outside the acceptance ranges. It was found that this only affected the results of samples with an alpha-fetoprotein (AFP) concentration of less than 18 ng / ml. The Beckman Coulter company has directly informed the recipients of these batches. This information is intended for directors and correspondents of reactive vigilance for dissemination, where appropriate, to the services concerned.

Device

ACCESS® AFP
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER