Events

Recall of RENIN III GENERATION

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 INTERNATIONAL.

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
    2003-09-26
  • 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-lot-10b-du-dmdiv-renin-iii-generation-de-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 withdraws lot 10B (expiry 01/10/2003) from the market of the in vitro diagnostic medical device called RENIN III GENERATION, following a calibration defect which leads to an overestimation of the patient results of the order of 20%. This device is a kit for the radioimmunometric assay of active renin in human plasma.

Device

RENIN III GENERATION

Manufacturer

CIS BIO INTERNATIONAL
  • Source
    LAANSM