Events

Recall of TnI Ultra reagent

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 Siemens.

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
    2007-07-10
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/recommandations-concernant-le-reactif-tni-ultra-de-la-societe-siemens
  • 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 Siemens company has published, on 06/07/2007, recommendations to users of the TnI Ultra reagent used for the quantitative determination of cardiac troponin I. The users of this device concerned by this defect, in France, have received the following letter (10/07/2007) (74 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, managers health establishments and local correspondents of reactive vigilance for diffusion to the biology services concerned .. See also. Update on Tnl-Ultra reagent - SIEMEN. of 28/09/2007

Device

TnI Ultra reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Siemens

Manufacturer

Siemens
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    LAANSM