Events

Recall of Dako IDEIA Herpes Simplex Virus reagent

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 J2L.

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
    2004-04-13
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-un-lot-de-reactif-dako-ideia-herpes-distribue-par-j2l-elitech
  • 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 the Afssaps, the company J2L informed, on 09/04/2004, the users of the Dako IDEIA Herpes Simplex Virus reagent of a risk of false positive results justifying the withdrawal of a lot .. Users of this affected by this defect, in France, received the enclosed letter (09/04/2004) (23 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, health facility managers and local correspondents for reactive surveillance for dissemination to the relevant biology departments.

Device

Dako IDEIA Herpes Simplex Virus reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    J2L

Manufacturer

J2L
  • Source
    LAANSM