Events

Recall of Nichols Advantage® Specimen Diluent hGH

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
    2005-05-02
  • 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-dmdiv-nichols-advantage-r-diluant-echantillons-hgh-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 29.04.2005, Nichols Institute Diagnostics removed from the market all batches of the in vitro diagnostic medical device known as Nichols Advantage® Specimen Diluent hGH, reference 64-7756, after an underestimation of approximately 20 % of the final result for the diluted samples. This device is used to dilute the patient samples whose results are higher than the measurement range (> to 30ng / ml). It is used with the Nichols Advantage® hGH assay for the quantitative determination of human growth hormone levels in serum, on the Nichols Advantage® specialized machine. The company has directly notified the recipients of the offending lots by means of the message attached (29/04/2005) (11 KB) validated by the Afssaps .. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

Nichols Advantage® Specimen Diluent hGH

Manufacturer

Nichols Institute Diagnostics
  • Source
    LAANSM