Events

Recall of VITROS® AFP;VITROS® CA 19-9

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 Ortho-Clinical Diagnostics.

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
    2004-11-04
  • 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-vitros-ca-19-9-de-par-ortho-clinical-diagnostics
  • 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
    On November 3, 2004, Ortho-Clinical Diagnostics removed lot 660 (per 28.01.05) from the in vitro diagnostic medical device called VITROS® AFP - reference 192 5551 and lot 670 (per 07.12.04). ) of the in vitro diagnostic medical device known as VITROS® CA 19-9 - reference 680 0040, following the finding of results inferior to those expected; this anomaly is due to the production of a light signal lower than that expected by some wells. The company Ortho-Clinical Diagnostics has directly informed the recipients of the incriminated lots by means of the message attached (03/11/2004) ( 22 kb). The competent authorities have been notified directly by the manufacturer. This information is addressed to the directors of health establishments and correspondents of réactovigilance for diffusion, if necessary, with the services concerned.

Device

VITROS® AFP;VITROS® CA 19-9

Manufacturer

Ortho-Clinical Diagnostics