Events

Recall of TPHA kit for the detection of anti-Treponema pallidum antibodies (serodiagnosis of syphilis)

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 EUROBIO.

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
    2004-02-18
  • 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-deux-lots-du-kit-tpha-de-la-societe-eurobio
  • 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 Eurobio informed, on February 13, 2004, the users of the TPHA kit for the detection of anti-Treponema pallidum antibodies (serodiagnosis of syphilis), the removal of two lots with a sensitivity defect susceptible to give false negative results. Health facilities, as well as the EFS concerned by this withdrawal, received the attached letter (13/02/2004) (82 KB). The competent European authorities have been informed of this measure by Afssaps.

Device

TPHA kit for the detection of anti-Treponema pallidum antibodies (serodiagnosis of syphilis)
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    EUROBIO

Manufacturer

EUROBIO
  • Source
    LAANSM