Events

Recall of TPHA ki

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
    2003-02-07
  • 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-dispositif-medical-de-diagnostic-in-vitro-denomme-kit-tpha-ref--shasyp00-8t-par-les-laboratoires-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
    The EUROBIO laboratories are removing from the market Lot 21903R (January 2004 issue) of the in vitro diagnostic medical device called: TPHA kit - reference SHASYP00-8T, due to a problem of stability of one of the components of the kit leading to a decrease results obtained for the positive control (titre of 640 instead of 2560) and for the patient samples and possibly, as part of the qualitative method in the serodiagnosis of syphilis, to a possibility of false negative results. as a precautionary measure, in agreement with AFSSAPS, biologists are asked to reconsider all syphilis serodiagnostics concerned by this batch (present on the French market since November 18, 2002) and rendered negative. A note. : in the case of a negative test, the instructions for use of the kit advise to complete the profile of the results by practicing a RPR / VDRL-Coal on the sample. This device allows the detection and the titration of the anti-antibodies. Treponema pallidum in the serodiagnosis of syphilis.

Device

TPHA ki
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    EUROBIO

Manufacturer

EUROBIO
  • Source
    LAANSM