Events

Field Safety Notices about Exacto Pro test and others

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Biosynex.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-06-08
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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

Manufacturer

Biosynex
  • Manufacturer Parent Company (2017)
    Biosynex
  • Source
    AMPMDRS