Events

Recall of STA Neoplastine CI Plus 5

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 Diagnostiga Stago.

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
    2010-02-10
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-d-un-lot-de-reactif-sta-neoplastine-ci-plus-5-commercialise-par-la-societe-diagnostica-stago
  • 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
    In agreement with Afssaps, the company Diagnostiga Stago, informed, on 05/02/2010, the users of the reagent STA Neoplastine CI Plus 5 reference 00606 of a recall of lot 105470. The users of this device concerned by this defect , in France, have received the following letter (10/02/2010) (34 KB). The competent European authorities have been informed of this measure by the manufacturer and Afssaps. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.

Device

STA Neoplastine CI Plus 5
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Diagnostiga Stago

Manufacturer

Diagnostiga Stago