Events

Recall of Membrane box for electrode E 1001

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.

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
    2002-03-06
  • 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-membranes-pour-electrodes-e-1001-analyseurs-abl-serie-700-de-radiometer2
  • 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
    (Cancels and replaces the mail of 28/02/2002: because other batches than those previously mentioned are concerned by this withdrawal, however the message addressed to the users remains identical .. The company RADIOMETER withdraws from the market all the batches lower than the lot R0080 (expiry date 12/2003) of the in vitro diagnostic medical device called membrane box for electrode E 1001 - code 942-058 reference D711 (accessories of analyzers ABL series 700) .. Application range: accessories of analyzers ABL 700 series (blood gas and electrolyte analyzers) .. analyzers used for emergency tests Description of the defect: possible absence, in some membranes, of the layer of cellophane which is in contact with the sample and which facilitates the elimination, by rinsing, after the test Risk of minor analytical bias on the parameters pH, Na, K, Ca, Cl at a high analytical rate (more than 50 analyzes per day).

Device

Membrane box for electrode E 1001
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    RADIOMETER

Manufacturer

RADIOMETER
  • Source
    LAANSM