Events

Recall of Elecsys Troponine T

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 Roche Diagnostics.

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
    2005-12-30
  • 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-dmdiv-elecsys-troponine-t-roche-diagnostics
  • 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
    On 28/12/2005, Roche Diagnostics withdrew lot 171924-02 from the in vitro diagnostic medical device called Elecsys Troponine T reference 12017644. This device is used for the quantitative determination of Troponin T in serum and the human plasma on the Elecsys 1010/2010 and MODULAR ANALYTICS E170 analyzers (Elecsys module). This measurement follows the demonstration that some R2 reagent bottles do not contain the Ruthenium-labeled anti-troponin T antibody reagent. This anomaly is detected during quality checks. The company has directly notified the recipients of the offending batch by means of the attached message (28/12/2005) (45 KB) validated by Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Elecsys Troponine T
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics