Events

Recall of BD Vacutainer® Glass Tube with Citrate

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 BECTON DICKINSON.

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
    2005-06-02
  • 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-tube-bd-vacutainer-r-en-verre-avec-citrate-becton-dickinson-france
  • 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 30, 2005, Becton Dickinson France SA withdrew from the market lot 5005913 (per 06/2006) of the in vitro diagnostic medical device known as BD Vacutainer® Glass Tube with Citrate (reference 367704) following the implementation of evidence of an excessive amount of citrate in some tubes in this lot altering the blood / anticoagulant ratio, resulting in longer coagulation times and a lower concentration of coagulation markers. The company directly notified the recipients of the batch incriminated by means of the attached message (30/05/2005) (89 ko) validated by the 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

BD Vacutainer® Glass Tube with Citrate
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON