Events

Recall of Quick Bio G, tube of 20 strips

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 Biomedix.

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
    2006-05-24
  • 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-de-reactif-quick-bio-g-tube-de-20-bandelettes-biomedix
  • 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
    In agreement with Afssaps, the company Biomedix removed from the market, May 23, 2006, lot 04.11.09 (per 11/2006) pregnancy tests for health professionals called Quick Bio G, tube of 20 strips , for false negative results obtained on this lot. The users of this device concerned by this defect, in France, received the attached mail (23/05/2006) (9 KB). This information is intended especially for the directors of health establishments and local correspondents for reactivovigilance. This reminder only concerns France.

Device

Quick Bio G, tube of 20 strips
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Biomedix

Manufacturer

Biomedix
  • Source
    LAANSM