Events

Recall of DYNOtest anti-TGn

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 BRAHMS France.

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
    2003-06-17
  • 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-lots-du-dmdiv-dynotest-anti-tgn-de-par-la-societe-brahms-france
  • 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 BRAHMS France withdraws from the market batches 302712 (per.05.06.03), 302715 (per.03.07.03) and 302717 (per.16.07.03) of the in vitro diagnostic medical device called DYNOtest anti-TGn - references 27.1 and 27.5, due to a lack of "coating" in human anti-thyroglobulin autoantibodies of the tubes used in the composition of the kits. This defect leads to obtaining overestimated results (of the order of 15 to 30 IU / ml). This device makes it possible to assay the anti-thyroglobulin antibodies in human serum by a radioimmunological technique by competition.

Device

DYNOtest anti-TGn
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BRAHMS France

Manufacturer

BRAHMS France
  • Source
    LAANSM