Events

Recall of BD Unopette

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
    2003-05-19
  • 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-bd-unopette-de-par-la-societe-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 lot 2282005 from the market for the in vitro diagnostic medical device known as BD Unopette - reference 365851, following the discovery of an abnormality in its production that could lead to the lysis of red blood cells and an underestimation of their count. This device allows the counting of red blood cells in manual technique.

Device

BD Unopette
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON