Events

Recall of Creatinine

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 BIOCODE HYCEL.

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
    2005-10-27
  • 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-creatinine-biocode-hycel-france-sa
  • 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 October 26, 2005, Biocode-Hycel France SA withdrew from the market lot 014 (expiry 03/2007) of the in vitro diagnostic medical device called Creatinine (references BC4002 / 200 and BC4002 / XS). This measure follows the detection of an instability of this batch with the preservation resulting in an abnormal degradation of the performances resulting in a decrease of the sensitivity. This device is used for the quantitative determination of the creatinine in the urine, serum or plasma. The company has directly notified the recipients of the offending lot by means of the attached message (26/10/2005) (19 KB) validated by Afssaps. The competent European authorities concerned are informed by the Belgian competent authority. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Creatinine
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOCODE HYCEL

Manufacturer

BIOCODE HYCEL
  • Source
    LAANSM