Events

Recall of Rapid Laboquick Anti-HIV 1/2 Rapid Test Cassette Rapid Test Kit

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 Koroglu.

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
    2013-12-12
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/test-rapide-d-orientation-diagnostique-laboquick-anti-hiv-1-2-cassette-rapid-test-kit-koroglu-retrait-de-produit
  • 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 12/12/2013, the Ansm distributed safety information to users of the Laboquick Anti-HIV Rapid Test Rapid Test Kit 1/2 Rapid Test Kit manufactured by the company Koroglu and distributed in France by the company AllDiag .. The users concerned, in France, have received the attached mail (12/12/2013) (31 KB). The competent European authorities have been informed of this measure by the ANSM. This information is addressed to the directors of health establishments, local correspondents of reactovigilance as well as to the medical biologists for diffusion to the users concerned .. Read also. Rapid Laboquick Anti-HIV ½ HIV test manufactured by Koroglu: Withdrawal, suspension of placing on the market and use (12/12/2013) - Information Point

Device

Rapid Laboquick Anti-HIV 1/2 Rapid Test Cassette Rapid Test Kit
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Koroglu

Manufacturer

Koroglu
  • Manufacturer Parent Company (2017)
    Koroglu
  • Source
    LAANSM