Events

Recall of Access digoxin reagent reference 33710

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
    2005-03-10
  • 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-reactif-digoxine-access-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
    On March 9, 2005, the company BECKMAN COULTER withdrew from the market batches 323171 (expiry 31/12/05), 416110 (expiry 31/03/06) and 417703 (expiry 30/06/06) of the medical diagnostic device in vitro called Access digoxin reagent reference 33710 following a possibility of increasing the inaccuracy of the assay (at +/- 20 to 25%) at the end of pack reagents (10 - 15 final tests) inducing a risk of erroneous patient results if no quality control is performed in parallel. BECKMAN COULTER directly notified the recipients of the offending batches by means of the attached message (10/03/2005) (32 KB) validated by Afssaps. The relevant European authorities concerned 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.

Device

Access digoxin reagent reference 33710
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER