Events

Recall of KALLESTAD / Blades Hep2

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 Bio-Rad.

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
    2003-03-19
  • 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-du-dispositif-medical-de-diagnostic-in-vitro-denomme-kallestad-lames-hep2-ref--30469-30470-30845-de-la-societe-bio-rad
  • 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 Bio-Rad withdraws from the market lot 915005 (per 06.05.03) of reference 30470 and lot 916338 (per 06.05.03) of reference 30845 of the in vitro diagnostic medical device called KALLESTAD / Blades Hep2 - references 30469/30470/30845 (respectively 24, 12 and 6-well blades), following customer complaints resulting from results rendered falsely negative during a national quality control organized by the AFSSAPS. These blades manufactured according to a the "old generation" procedure appear to be less efficient than blades made according to a "new generation" procedure. This device allows the detection and semi-quantitative determination of anti-nuclear autoantibodies by indirect immunofluorescence technique.

Device

KALLESTAD / Blades Hep2
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad