Events

Recall of CAPILLARYS IMMUNOTYPING

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 SEBIA.

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
    2005-04-01
  • 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-dmdiv-capillarys-immunotyping-sebia
  • 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 29 March 2005, SEBIA withdrew from the market batches 28064/01, 28064/02, 28064/03, 28064/04 of the in vitro diagnostic medical device CAPILLARYS IMMUNOTYPING reference 2100 following the identification of the specificity of a lot of anti-Ig M used, which can lead to an erroneous diagnosis of biclonal gammapathy when there is only one monoclonal immunoglobulin .. This device is used for the detection and characterization of monoclonal proteins ( immunotyping) in human serum by capillary electrophoresis in the automatic system CAPILLARYS .. The company has directly notified the recipients of the offending lots by means of the message attached (29/03/2005) (63 KB) validated by Afssaps. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

CAPILLARYS IMMUNOTYPING
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    SEBIA

Manufacturer

SEBIA
  • Source
    LAANSM