Events

Recall of MONOLISA HCV Ag-Ab ULTRA kits

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 BIORAD.

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
    2006-11-10
  • 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-de-trousses-de-reactif-monolisa-hcv-ag-ab-ultra-societe-biorad
  • 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
    In agreement with Afssaps, the company BIORAD informed, on 07/11/06, the users of MONOLISA HCV Ag-Ab ULTRA kits of the withdrawal of certain batches following the results of the stability studies showing a decrease of activity. The users of this device concerned by this defect in France have received the following letter (07/11/2006) (2658 ko). The competent European authorities have been informed of this measure by the manufacturer. addressed to laboratory managers, health facility directors and local correspondents for reactive surveillance for dissemination to the concerned biology departments.

Device

MONOLISA HCV Ag-Ab ULTRA kits
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIORAD

Manufacturer

BIORAD
  • Source
    LAANSM