Events

Recall of IMMULITE 2000 intact PTH

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 DPC France.

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
    2004-04-15
  • 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-2-lots-du-dmdiv-immulite-2000-pth-intacte-de-par-dpc-france
  • 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
    DPC France has withdrawn lots 117 (per 31.08.04) and 118 (per 31.10.04) from the market for the in vitro diagnostic medical device known as IMMULITE 2000 intact PTH - references L2KPP2 and L2KPP6, following the observation in some cases of an increase in the values ​​of the results. This device is intended for the assay, on the Immulite 2000 analyzer, of the intact parathyroid hormone (Parathormone, intact PTH) in the serum.

Device

IMMULITE 2000 intact PTH
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DPC France

Manufacturer

DPC France
  • Source
    LAANSM