Events

Recall of PERSONA

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 UNIPATH DIAGNOSTICS SA.

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
    2000-11-09
  • 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-de-lots-de-reactif-denomme-persona
  • 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
    Batches TS0535A and TS0536 of the reagent called PERSONA - box of 8 reagent tests / ref. 501027 and lot SP0227 of the reagent called PERSONA - basic packaging / ref. 501035 of the company UNIPATH DIAGNOSTICS SA are withdrawn from the market due to a stability problem resulting in a significant increase in the number of "red" days. This incident has consequences only on the comfort of the user and not on the reliability of the test.

Device

PERSONA

Manufacturer

UNIPATH DIAGNOSTICS SA
  • Source
    LAANSM