Events

Recall of BD Vacutainer citrate tubes

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
    2003-12-08
  • 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-tubes-bd-vacutainer-citrate-par-becton-dickinson
  • 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
    Becton Dickinson withdraws from the market lot 3211398 (per 01.05) of the in vitro diagnostic medical device called BD Vacutainer citrate tubes - reference 367714, following the detection of the presence of residual amount of CTAD solution (sodium citrate with acetic acid, theophylline, adenosine and dipyridamole) for a very limited number of tubes, giving a yellow color to the normally colorless additive. The possible presence of these compounds in the citrate medium has no impact on the results of coagulation and haemostasis tests; it could have some results on the platelet function tests but only about 1% of these tests are done with this tube reference.

Device

BD Vacutainer citrate tubes
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON