Events

Recall of Unicel DxI 800 Access Immunoassay System

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
    2006-03-08
  • 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-cuvettes-reactionnelles-pour-systeme-d-immunoanalyse-unicel-dxi-800-access
  • 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 6, 2006, Beckman Coulter withdrew from the market batches 05180160, 05200160, 05250160, 05280160, 05300160, 05310160, 05350160, 05360160 of the in vitro diagnostic medical device called reaction cuvettes for Unicel DxI 800 Access Immunoassay System, reference 386167, following the demonstration of slight molding defects. This is a precautionary measure because this defect does not affect the results of the patients tested. The company has directly notified the recipients of the offending lots by means of the attached message (08/03/2006) (90 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of the establishments of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

Unicel DxI 800 Access Immunoassay System
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER