Events

Avis De Sécurité sur Exacto Pro test and others

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Biosynex.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-06-08
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    We would like to inform you about the suspension of the placing on the market, of the use and of the withdrawal of the in vitro medical devices exacto pro test hiv ref 857318, biosynex hivtop ref 1150004, hivtop ref 5059, immunoquick hiv ref 0556_k25, biosynex hcv ref 1150002, hcvtop ref 5058, immunoquick hcv ref 0557_k25, biosynex hbv ref 1150003, hbvtop ref 5060, immunoquick hbsag ref 0558_k25. this decision follows an inspection at biosynex from the ansm (agence nationale de sécurité du médicament et des produits de santé), our french health authority. this inspection was due to the fact that the who highlighted negligence and non- compliance at one of our subcontractor’s facilities. based on the negligence and non-compliance observed by the who and the ansm, biosynex has decided to suspend the manufacturing, the commercialization and the use of these devices. we will also withdraw and recall all the tests until they comply again with the applicable regulations.

Device

Exacto Pro test and others
  • Modèle / numéro de série
  • Manufacturer
    Biosynex

Manufacturer

Biosynex
  • Société-mère du fabricant (2017)
    Biosynex
  • Source
    AMPMDRS