Recall of VIDAS AFP

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 BIOMERIEUX.

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    The company BIOMERIEUX withdraws from the market the batch 775364001 (per 13.04.04) of the in vitro diagnostic medical device called VIDAS AFP - reference 30413, following a problem of stability of one of the components of the cartridge-reagents resulting in a reduction of signal obtained with the cabinet calibrator and the possibility of out of standard low values ​​preventing the use of the device. A note. : the possibility of underestimation of patient results is 10% maximum over the entire period covering two recalibrations (ie 14 days). This device allows the determination of alpha-fetoprotein (AFP) in serum or plasma or amniotic fluid, on the VIDAS automaton.


  • Model / Serial
  • Product Description
  • Manufacturer