Events

Recall of IMMULITE 2000 Testosterone Total

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
    2006-01-10
  • 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-et-information-sur-un-lot-du-dmdiv-immulite-2000-testosterone-totale-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
    On January 6, 2006, DPC France withdrew from the market part of lot 126 of the in vitro diagnostic medical device called IMMULITE 2000 Testosterone Total reference L2KTW. This device is used for the quantitative determination of total testosterone in serum with the IMMULITE 2000 analyzer. This decision is motivated by the fact that this lot contains a raw material that could interfere with the IMMULITE 2000 Estradiol assay (ref. L2KE2) thus causing an overestimation of the concentrations observed in Estradiol. Since the performance of lot 126 is not affected by this raw material, this recall only concerns recipients of the lot who use the IMMULITE 2000 assay on the same machine. estradiol. The company has directly notified all recipients of the offending lot by means of the message attached (06/01/2006) (134 KB) validated by Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

IMMULITE 2000 Testosterone Total
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DPC France

Manufacturer

DPC France
  • Source
    LAANSM