Events

Recall of Capillary Adapters

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 SA.

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
    2005-07-01
  • 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-adaptateurs-pour-capillaires-radiometer-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 June 29, 2005, Radiometer SA withdrew from the market the batches included between lot 041643 inclusive and lot 045124 inclusive, of the in vitro diagnostic medical device called capillary adapters, reference 906-018. This decision follows a manufacturing defect of the adapter that fits poorly on the capillary and on the suction probe causing air suction that mixed with the sample leads to a bias on the parameter results pO2 .. This device is used with analyzers ABL 5 and BPH 5 .. The company has directly notified the recipients of the incriminated lots by means of the message attached (29/06/2005) (40 KB) validated by Afssaps .. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Capillary Adapters
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Radiometer SA

Manufacturer

Radiometer SA
  • Source
    LAANSM