Events

Recall of GONOLINE DUO

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
    2002-04-09
  • 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-reactif-gonoline-duo-ref--56524-de-la-societe-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
    The company BIOMERIEUX withdraws from the market lot DC003 (per 05.07.02) of the in vitro diagnostic medical device called: GONOLINE DUO - reference 56 524, following the detection during a routine check of the batch in progress. validity, the lack of growth of one of the strains of Neisseria gonorrhoeae used for batch release. This device allows the demonstration of Neisseria gonorrhoeae on samples taken at the endocervical, urethral or rectal level. Patient records for which specimens were negative should be re-examined.

Device

GONOLINE DUO
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX