Events

Field Safety Notices about VIDAS TOXO IgM

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 bioMérieux SA.

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
  • 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
    Following a complaint from a customer related to discrepant results observed when testing heat inactivated sera, biomérieux performed an investigation concluding that the performance of vidas toxo igm kit using heat inactivated sera (56°c for 30 minutes) is not in accordance with the performance characteristics as stated in the ifu. the investigation confirmed that the index results obtained with inactivated sera are lower compared to values obtained with fresh sera. .

Device

VIDAS TOXO IgM
  • Model / Serial
    1003987950 11/02/2016 1004061730 01/03/2016 1004084290 26/03/2016 1004105910 02/04/2016 1004119920 11/04/2016 1004163410 26/04/2016 1004194060 03/05/2016 1004210630 16/05/2016 1004255080 20/05/2016 1004261950 31/05/2016 1004296300 28/06/2016 1004307590 03/07/2016 1004355660 18/07/2016 1004392080 29/07/2016 1004430660 16/08/2016 1004439320 22/08/2016 1004487160 12/09/2016 1004504650 18/09/2016 1004520730 27/09/2016 1004533690 29/09/2016 1004614010 14/11/2016
  • Manufacturer
    bioMérieux SA

Manufacturer

bioMérieux SA