Events

Recall of NucliSens EasyQ® HIV-1

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 BIOMERIEUX.

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
    2005-04-13
  • 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-nuclisens-easyq-r-hiv-1-v1-1-biomerieux
  • 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 11, 2005, the company bioMérieux removed from the market the batch 04101505 of the in vitro diagnostic medical device called NucliSens EasyQ® HIV-1 v1.1 reference 285029 following the detection of a low contamination of the Calibrator included in the box, This device is used for the quantitative determination of HIV-1 RNA in human EDTA plasma in order to control the effects of antiretroviral therapy. It must not be used to carry out an HIV-1 test. The company has directly notified the recipients of the offending batch by means of the attached message (11/04/2005) (10 KB) validated by the Afssaps .. The competent European 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

NucliSens EasyQ® HIV-1
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX