Events

Recall of Nichols Advantage® Bio-Intact PTH (1-84)

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 Nichols Institute Diagnostics.

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
    2005-04-12
  • 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-lots-dmdiv-nichols-advantage-r-bio-intact-pth-1-84-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 April 8, 2005, Nichols Institute Diagnostics withdrew lots 62-402622, 62-402622B, 62-402622C, 62-402622D from the in vitro diagnostic medical device known as Nichols Advantage® Bio-Intact PTH (1-84). ) reference 62-7040 following the demonstration that these batches were no longer in conformity with the information indicated in the instructions for use, concerning functional sensitivity, reproducibility, parallelism and recovery. This device is used with the Nichols Advantage® specialized automaton for measuring parathyroid hormone levels in serum, EDTA plasma and heparinized plasma. The relevant European Competent Authorities are informed directly by the manufacturer. 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

Nichols Advantage® Bio-Intact PTH (1-84)

Manufacturer

Nichols Institute Diagnostics
  • Source
    LAANSM