Events

Recall of Urinary Proteins

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
    2006-03-10
  • 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-de-lots-du-dmdiv-proteines-urinaires-biocode-hycel
  • 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 8, 2006, Biocode-Hycel removed from the market batches 014101 (per 06/2007) and 014301 (per 06/2007) of the in vitro diagnostic medical device called Urinary Proteins (references BC4001 / 200 and BC4001). / XS). This device is used for the quantitative determination of proteins in the urine and cerebrospinal fluid samples. This measurement follows the detection of an abnormal degradation of the performances resulting in a reduction of the Optical Density of the cerebrospinal fluid. responsiveness and sensitivity .. The company has directly notified the recipients of the offending lots by means of the attached message (08/03/2006) (19 KB) validated by Afssaps .. This information is intended for those responsible for laboratory, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

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

Manufacturer

BIOCODE HYCEL
  • Source
    LAANSM