Events

Recall of ELSA CA 15-3

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 CIS bio.

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
    2004-02-09
  • 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-elsa-ca-15-3-de-par-cis-bio-international
  • 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
    CIS bio international is withdrawing batch 385C (per.10.03.04) from the in vitro diagnostic medical device known as ELSA CA 15-3 following the possible presence of some defective "coated" fins tubes in certain kits. These defective tubes lead to obtaining results close to zero which invalidate the assay. This device is intended for the radioimmunological assay of the CA 15-3 marker (Cancer Antigen 15-3); marker associated with human breast tumors.

Device

ELSA CA 15-3
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    CIS bio

Manufacturer

CIS bio
  • Source
    LAANSM