Events

Recall of Reagent EA50

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 Labonord.

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
    2013-07-29
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/reactif-ea50-labonord-rappel
  • 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
    LABONORD has informed EA50 reagent users of the recall of four batches of the Labonord EA50 3B 5L presentation, four lots of the Q Path EA50 450 mL pouch presentation, and three lots of the Q Path EA50 2.5L submission. The users concerned, in France, received the attached mail (29/07/2013) (277 KB). This information is addressed to the directors of health establishments and local correspondents of reactovigilance for diffusion to the concerned services.

Device

Reagent EA50
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Labonord

Manufacturer

Labonord
  • Manufacturer Parent Company (2017)
    Labonord
  • Source
    LAANSM