Events

Recall of Radiometer ABL 800 FLEX

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 Radiometer SAS.

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
    2006-03-17
  • 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-d-un-lot-du-dmdiv-flacons-de-rincage-radiometer-s-a-s
  • 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 14, 2006, Radiometer SAS withdrew RD-02 lot from the in vitro diagnostic medical device named Rinse Flasks reference 944-132 S 4980 .. These are used on analyzers Radiometer ABL 800 FLEX .. This measure follows the detection of an air intake which prevents the aspiration of the rinsing liquid by the automaton, which then displays a "rinsing error" message. The company has directly informed the recipients of the incriminated lot by means of the attached message (14/03/2006) (23 KB) validated by Afssaps. 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

Radiometer ABL 800 FLEX
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Radiometer SAS

Manufacturer

Radiometer SAS
  • Source
    LAANSM