Events

Recall of Ethyl Alcohol

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 Thermo Electron SAS.

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
    2005-05-20
  • 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-alcool-ethylique-thermo-electron-sas
  • 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 May 19, 2005, the company Thermo Electron SAS withdrew from the market lot 0321 (per 08/2005) of the in vitro diagnostic medical device called Ethyl Alcohol reference 981680 following the detection of a decrease in the sensitivity of this batch of reagent results in a decrease in the accuracy of the results. This device is used for the in vitro quantitative determination of the activity of ethyl alcohol in human serum, plasma or urine using Konelab 20XT analyzers. , 30 and 60, for the monitoring of intoxications with ethyl alcohol .. The company has directly notified the recipients of the offending lot by means of the attached message (19/05/2005) (54 KB) validated by Afssaps .. This information is intended for laboratory managers, directors of health establishments and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Ethyl Alcohol

Manufacturer

Thermo Electron SAS
  • Source
    LAANSM