Events

Recall of Ki67-MM1 Bond Ready To Use Reagent and Ki67-MM1 Concentrate

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 Leica Biosystems.

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
    2015-05-13
  • 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-ki67-mm1-bond-ready-to-use-et-ki67-mm1-concentrate-leica-biosystems-rappel-de-lots
  • 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
    Leica Biosystems informed the users of Ki67-MM1 Bond Ready To Use and Ki67-MM1 Concentrate reagents of a batch recall. The users concerned, in France, have received the attached mail (13/05/2015) (1906 ko). This information is addressed to the directors of health establishments and local correspondents of reactive vigilance for diffusion to the concerned services.

Device

Ki67-MM1 Bond Ready To Use Reagent and Ki67-MM1 Concentrate
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Leica Biosystems

Manufacturer

Leica Biosystems