Events

Recall of Elsa TSH NN Reagent

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 CisBio Bioassays.

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
  • Event ID
    R1714786
  • Date
    2017-09-22
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/biochimie-reactif-elsa-tsh-nn-cisbio-bioassays-rappel
  • 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
    ANSM has been informed of the implementation of a batch withdrawal carried out by CisBio BIOASSAYS. The users concerned have received the attached mail (22/09/2017) (30 KB). This safety action is registered at ANSM under the number R1714786.

Device

Elsa TSH NN Reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    CisBio Bioassays

Manufacturer

CisBio Bioassays