Events

Recall of ImmunoComb II HCV 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 INVERNESS MEDICAL France.

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
    2006-02-17
  • 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-immunocomb-ii-hcv-igg-inverness-medical-france
  • 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 February 17, 2006, INVERNESS MEDICAL France withdrew lot 051102 from the in vitro diagnostic medical device called ImmunoComb II HCV IgG reference 60455002FR. This device is a rapid test for IgG antibodies against hepatitis C virus in human serum and plasma. This follows a demonstration of a drop in reagent stability that appears to affect the overall sensitivity of the kit with a risk of causing false negative results. The company has directly notified the recipients of the offending lot by means of the attached message (17/02/2006) (22 KB) validated by Afssaps. This message is completed by a letter Afssaps (17/02/2006) (18 ko) on the need to carry out the retest of all sera made negative, with this lot of reagent, using another reagent CE marked. The competent European authorities concerned are informed by Afssaps. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned. Mail Inverness Medical France (17/02/2006) (22 KB Courrier Afssaps (17/02/2006) (18 KB)

Device

ImmunoComb II HCV IgG

Manufacturer

INVERNESS MEDICAL France
  • Source
    LAANSM