Events

Recall of CARDIOLISA IgG from / by BMD

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 BMD (BioMedical Diagnostics).

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
    2003-07-31
  • 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-d-un-lot-du-dispositif-cardiolisa-igg-de-par-b-m-d
  • 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 BMD (BioMedical Diagnostics) withdraws from the market the lot 030401 (per.31.01.04) of the in vitro diagnostic medical device called CARDIOLISA IgG - references HM 001; HM 001A and HM 004, following the possibility of obtaining false positive results. This device allows the assay of anti-cardiolipin autoantibodies (anti-phospholipid antibodies) of class IgG, in human serum or plasma by immunoenzymatic method. These antibodies are sought especially in the context of thromboses, lupus (systemic lupus erythematosus, drug-induced lupus ..).

Device

CARDIOLISA IgG from / by BMD

Manufacturer

BMD (BioMedical Diagnostics)
  • Source
    LAANSM