Events

Recall of hGH IRMA

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 IMMUNOTECH.

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
    2003-09-30
  • 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-de-2-lots-du-dm-div-hgh-irma-ref--im1397-de-par-immunotech
  • 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
    IMMUNOTECH withdraws from the market batches 89 and 89B (per 13.10.03) of the in vitro diagnostic medical device called: hGH IRMA - reference IM1397, following the possibility of deterioration of the standard liquid range (lot 1001) - contained in the kits of the device - leading to an overdose of the samples .. This device allows the immunoradiometric assay (I 125) of growth hormone in human serum and plasma.

Device

hGH IRMA
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    IMMUNOTECH

Manufacturer

IMMUNOTECH
  • Source
    LAANSM