Events

Recall of Alkaline Phosphatase

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
    2005-07-13
  • 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-phosphatase-alcaline-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 July 11, 2005, the company BIOCODE HYCEL withdrew from the market lot 016 (per 30/04/2006) of the in vitro diagnostic medical device called Alkaline Phosphatase reference R5A650A following a filling to 50 ml of reagent bottles REAG1 ( buffer) instead of 40 ml. This defect causes an overflow of the liquid during the preparation of the working solution by pouring the REAG 2 (substrate) into the REAG 1 (buffer) vial. This device is a kit used for the quantitative determination of the alkaline phosphatase in the serum or plasma samples. The company has directly notified the recipients of the offending batch by means of the attached message (11/07/2005) (21 KB) validated by Afssaps. This information is intended for those responsible laboratories, the directors of health establishments and the reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

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

Manufacturer

BIOCODE HYCEL
  • Source
    LAANSM