Events

Recall of Nichols Advantage® ACTH

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
    2005-05-30
  • 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-nichols-advantage-r-acth-nichols-institute-diagnostics
  • 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 May 26, 2005, Nichols Institute Diagnostics withdrew from the market Lot 62-500040 (Per 20.06.05) of the in vitro diagnostic medical device known as Nichols Advantage® ACTH Reference 62-7004 following the identification of the nonconformity of this batch with the information indicated in the instructions for use, concerning the correlation with ACTH IRMA technique (immuno-radiometric assay). This device is used for the quantitative determination of the ACTH (corticotropic hormone) concentrations in human plasma supplemented with EDTA on Nichols Advantage®. The company has directly notified the recipients of the offending lot by means of the attached message (26/05/2008) (11 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

Nichols Advantage® ACTH
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DPC France

Manufacturer

DPC France
  • Source
    LAANSM