Events

Recall of Phospho-Lisa ™ IgG and IgM

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.

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
    2004-09-27
  • 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-dmdiv-phospho-lisa-igg-et-igm-de-par-bmd
  • 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 September 24, 2004, the company BMD withdrew the lot P040601 (per 31.03.05) from the in vitro diagnostic medical device called Phospho-Lisa ™ IgG and IgM - reference HM 007 following the detection of a IgM positive control stability problem - included in the kit - which may lead to obtaining out-of-specification values ​​(invalidation of the test series). This device allows the detection of anti-phospholide antibodies of the IgG and IgM type in the body. serum or human plasma.

Device

Phospho-Lisa ™ IgG and IgM
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BMD

Manufacturer

BMD
  • Source
    LAANSM