Events

Recall of Infectious Mononucleosis Kit

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 OXOID.

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
    2006-03-17
  • 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-d-un-lot-du-dmdiv-coffret-mononucleose-infectieuse-oxoid
  • 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
    On March 14, 2006, the OXOID company withdrew from the market lot 382735 of the in vitro diagnostic medical device called Infectious Mononucleosis Kit reference DR0680M following the possible occurrence of low false positive results with this set of box. The company has directly notified the recipients of the offending batch by means of the attached message (14/03/2006) (15 KB) validated by Afssaps. This information is intended for laboratory managers, directors health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

Infectious Mononucleosis Kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    OXOID

Manufacturer

OXOID
  • Source
    LAANSM