Events

Recall of Reactive HIV Test Cassette and HCV Cassette Test

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 Orgentec SAS.

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
  • Event ID
    R1605925
  • Date
    2016-08-01
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/reactif-hiv-test-cassette-et-hcv-test-cassette-orgentec-sas-rappel-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
    Following the product recall initiated by the company Biosynex, following an inspection of it by the ANSM, the Orgentec distributor informed the users of the quick tests HIV Test Cassette and HCV Test Cassette of the withdrawal of these products. The users concerned have received the attached mail (01/08/2016) (359 KB). This safety action is registered with the ANSM under the number R1605925.

Device

Reactive HIV Test Cassette and HCV Cassette Test
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Orgentec SAS

Manufacturer

Orgentec SAS