Events

Recall of SERODIA HIV;SERODIA HIV1/2

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 BAYER 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
    1999-11-10
  • 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-reactifs-de-depistage-des-anticorps-anti-vih2
  • 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 Advisory Committee for the Registration of Reagents. In view of the results of this re-evaluation and following the opinion of the Advisory Committee on the Registration of Reagents (CCER), the French Agency for the Safety of Health Products decided to withdraw from the market of six reagents on 16 June 1999 (message from June 17, 1999). In addition to these decisions, the Agency decided on 9 November 1999 to proceed with the removal of the SERODIA HIV and SERODIA HIV1 / 2 reagents from BAYER DIAGNOSTICS, given the impossibility of improving the performance of these reagents, including sensitivity was close to the acceptance criteria adopted by the CCER.

Device

SERODIA HIV;SERODIA HIV1/2
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

BAYER DIAGNOSTICS
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    LAANSM