Events

Recall of Contour TS blood glucose meter

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 BAYER DIAGNOSTICS.

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
    2008-01-22
  • 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-plusieurs-lots-de-bandelettes-du-lecteur-de-glycemie-contour-ts-societe-bayer-healthcare
  • 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, the Bayer Healthcare company informed the health professionals concerned on 21/01/08 about the removal of several batches of strips from the Contour TS blood glucose meter due to a lack of quality and no impact. on the care of the patient. Depending on the lot numbers, two mails were sent. a first letter attached (22/01/2008) (29 ko) requesting the stop of use and the withdrawal of the strips was sent to the health professionals, hospital and private where this device was placed for demonstration. a second letter attached (22/01/2008) (15 KB) has been sent to wholesalers distributors, distributors and pharmacists in town. The relevant European Competent Authorities have been informed of this measure by the manufacturer.

Device

Contour TS blood glucose meter
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

BAYER DIAGNOSTICS
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    LAANSM