Events

Recall of Calcium R5C150A

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
    2006-07-07
  • 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-reactif-calcium-r5c150a-societe-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
    In agreement with Assaps, the company Biocode-Hycel Belgium proceeded to the withdrawal of a batch of reagent Calcium R5C150A on 05/07/06. The reagent has an increase in the optical density of the white which induces a rejection of the calibration by the PLC .. The users of this device concerned by this defect, in France, received the attached mail (05/07 / 2006) (23 KB). This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.

Device

Calcium R5C150A
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOCODE HYCEL

Manufacturer

BIOCODE HYCEL
  • Source
    LAANSM