Events

Recall of Flex Urea Nitrogen (BUN)

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 Dade Berhing.

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
    2008-01-31
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-cartouche-de-reactif-flex-uree-nitrogene-bun
  • 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 company Dade Berhing informed, on 28/01/08, the users of the reagent Flex Urea Nitrogen (BUN) for the urea assay on the Dimension system, a withdrawal of batch for lack of performance. The users of this device concerned by this defect, in France, have received the enclosed mail (28/01/2008) (35 KB). The competent European authorities have been informed of this measure by the manufacturer. addressed to laboratory managers, health facility directors and local correspondents for reactive surveillance for dissemination to the concerned biology departments.

Device

Flex Urea Nitrogen (BUN)
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Dade Berhing

Manufacturer

Dade Berhing
  • Source
    LAANSM