Events

Recall of Immulite / HBsAg;Immulite 2000 / HBsAg

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 DPC.

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
    2001-12-24
  • 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-lots-d-immulite-hbsag-de-la-societe-dpc
  • 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
    DPC withdraws from the market lot 501 (per 30.06.03) the reagent called Immulite / HBsAg - ref.LKHB1 and lot 501 (per 30.06.03) of the reagent called: Immulite 2000 / HBsAg - ref. L2KHB2 due to a low cps (beats per second) activity of the calibrator, which may increase the incidence of false positive results. note: the systematic neutralization test for all positive results, as recommended in the technical notice, avoids the rendering of a false positive.

Device

Immulite / HBsAg;Immulite 2000 / HBsAg
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DPC

Manufacturer

DPC
  • Source
    LAANSM