Events

Recall of MediSense Precise electrodes

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 ABBOTT MEDISENSE.

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
    2002-11-19
  • 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-consommables-de-lecteurs-de-glycemie-par-abbott-medisense
  • 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
    The ABBOTT MEDISENSE laboratory is recalling batches 89552 and 89553 (expiry 28.02.04) from the in vitro diagnostic medical device called: MediSense Precise electrodes - reference 99079-12 and recall of lot S007100 of the Precision QID kit - reference 98476-13 containing MediSense Précis / lot 89552 electrodes, due to a possible fault that could cause - for the majority of defective electrodes - the appearance of an error code rejecting any manipulation, or - for a very small number of defective electrodes (1.7 for 1 million) - a deviated result .. NB: these electrodes are consumable for use with MediSensPrecision QID blood glucose meters

Device

MediSense Precise electrodes
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ABBOTT MEDISENSE

Manufacturer

ABBOTT MEDISENSE
  • Source
    LAANSM