Events

Recall of OneTouch GlucoTouch Plus Blood Glucose Meters

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 LifeScan.

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
    2005-09-19
  • 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-du-dmdiv-lecteur-onetouch-r-glucotouch-r-plus-lifescan
  • 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
    In agreement with Afssaps, LifeScan is recalling OneTouch GlucoTouch Plus Blood Glucose Meters (L4266RBxxx Series to L5048RBxxx). Segments may be missing from the display and may result in an error in the reading of the result. Pharmacists in health facilities and / or pharmacies with these serial numbers should contact LifeScan on 0800 459 459 to inform them of the procedure to be followed. .. In addition, pharmacists are also asked to display in their dispensary the recall of devices mentioned and to inform users by means of the attached document (19/09/2005) (43 KB) which contains recommendations as well as the Verification of the display instructions. The relevant European Competent Authorities shall be informed directly by the manufacturer.

Device

OneTouch GlucoTouch Plus Blood Glucose Meters
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    LifeScan

Manufacturer

LifeScan