Events

Recall of Reflotron® GPT

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
    2004-11-04
  • 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-reflotron-gpt-de-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 October 20, 2004, Roche Diagnostics informed Afssaps of a withdrawal from the market of batch 23717731 (per 31.12.05) of the in vitro diagnostic medical device called Reflotron® GPT - reference 10745138, produced on October 12, 2004 , following the demonstration by the control laboratory of the supplier, of an anomaly of certain strips leading to the obtaining of erroneous results. The company Roche Diagnostics has directly informed the recipients of the offending lot by means of the attached message (20/10/2004) (7 KB) (not validated by Afssaps). This message is addressed to the directors of establishments health directors, laboratory directors and reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Reflotron® GPT
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics