Events

Recall of FusionQuant® Kit m-bcr

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 IPSOGEN SAS.

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
    2005-11-30
  • 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-fusionquant-r-kit-m-bcr-ipsogen-sas
  • 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 29/11/2005, the company IPSOGEN SAS withdrew the lot 05-04-01 (per 03/2006) from the in vitro diagnostic medical device called FusionQuant® Kit m-bcr reference FQPP-09-CE. This device is used for real-time Quantitative PCR analysis of the m-bcr Transcript in bone marrow or peripheral blood samples of patients with Acute Lymphocytic Leukemia or Ph-positive Chronic Myeloid Leukemia. m-bcr fusion has already been diagnosed. This measure follows the discovery of a defect in the stability of this batch resulting in the production of a standard ABL curve (for the control gene). ABL) having an upper slope and intercept in absolute value than the reference values, this invalidating the series of assays. The company has directly notified the recipients of the offending batch by means of the attached message (29/11/2005) (25 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of establishments health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

FusionQuant® Kit m-bcr
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    IPSOGEN SAS

Manufacturer

IPSOGEN SAS
  • Source
    LAANSM