Recall of Innotest HIV Ab 1.0.2.;Murex ICE HIV-1.0.2;Cobas Core anti-HIV-1/HIV-2 EIA DAGS;HIV 1+2 Double Check;Multispot HIV-1/HIV-2;Genie II HIV-1/HIV-2

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 INGE;MUREX DIAGNOSTICS;DIASORI;ROCHE DIAGNOSTIC;PBS ORGENICS;ORTHO CLINICAL DIAGNOSTIC;SANOF; DIAGNOSTICS PASTEUR.

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    As part of its vigilance competence for the products for which it ensures safety, the Agency has reassessed the sensitivity of all HIV-1 antibody test reagents in accordance with protocol approved by the Consultative Commission for the Registration of Reagents. In view of the results of this re-evaluation and after consulting the Consultative Commission for the Registration of Reagents, the French Agency for the Safety of Health Products has decided to withdraw from the market the following reagents. Innotest HIV Ab 1.0.2. (ref: K1076 / K1077) of the INGE Company. Murex ICE HIV-1.0.2 (ref: 100A / 150A / 200A) from MUREX DIAGNOSTICS and DIASORI Companies. Cobas Core anti-HIV-1 / HIV-2 EIA DAGS (Ref: 756059) of ROCHE DIAGNOSTIC. HIV 1 + 2 Double Check (ref: 332000) from the companies PBS ORGENICS and ORTHO CLINICAL DIAGNOSTIC. Multispot HIV-1 / HIV-2 (ref: 72269) from SANOF. and Genie II HIV-1 / HIV-2 (ref: 72323) DIAGNOSTICS PASTEUR