Events

Recall of Alcohol Reagent (ETOH)

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 BECKMAN COULTER.

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
    2005-06-30
  • 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-de-lots-du-dmdiv-reactif-alcool-etoh-beckman-coulter
  • 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 June 28, 2005, Beckman Coulter SA withdrew from the market batches M407255 and M409024 of the in vitro diagnostic medical device called Alcohol Reagent (ETOH) reference 474947 following possible quality control out of limits and calibration discharges before their expiry date. In addition, the expiry dates of lots M412090 and M503108 of the same device are shortened by four months. This device is used with the SYNCHRON LX, the UniCel 600/800 system (s) and the SYNCHRON Systems ETOH Calibrator. It is intended for the quantitative determination of ethanol in serum, plasma, human urine or human whole blood. The company has directly notified the recipients of the offending lots by means of the attached message (30 / 06/2005) (28 kb) validated by Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents. for dissemination, where appropriate, to the services concerned.

Device

Alcohol Reagent (ETOH)
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER