Events

Recall of Quick Tests

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 Biosynex SA.

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
    R1603451
  • Date
    2016-06-15
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/tests-rapides-biosynex-sa-rappel-de-produits
  • 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 an inspection by the ANSM, the company Biosynex informed the users of the rapid tests of the withdrawal of these products:. Biosynex HBV ,. Biosynex HCV ,. Biosynex HIVTOP ,. Exacto Pro HIV Test ,. HBVTOP ,. HCVTOP ,. HIVTOP ,. Immunoquick HbsAg ,. Immunoquick HCV. Immunoquick HIV. The affected users have received the attached mail. (15/06/2016) (132 ko This safety action is registered with ANSM under the number R1603451 Read more Immunoquick HIV reagent - Biosynex SA - Product recall (17/06/2016) HIVTOP reagent - Biosynex SA - Product recall (16/06/2016)

Device

Quick Tests
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Biosynex SA

Manufacturer

Biosynex SA
  • Manufacturer Parent Company (2017)
    Biosynex
  • Source
    LAANSM