Events

Recall of IFE Paragon IgG

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 BECKMAN COULTER.

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
    2004-02-19
  • 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-dmdiv-antiserum-paragon-ife-igg-par-beckman-coulter
  • 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 Beckman Coulter requests the discontinuation of batches M307329 and M307333 (per 31.10.04) of the antiserum IFE Paragon IgG contained dan. the Paragon IFE Antisera boxes - reference 444970. the IFE Paragon enclosures (gels and antisera) - reference 44493. and the Twin IFE Paragon enclosures - reference 446395. following the weakening of its greed (risk of reading more difficult) .. This reagent is used during the techniques of immunoelectrophoresis and can detect the presence of IgG in the samples.

Device

IFE Paragon IgG
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER