Events

Field Safety Notices about Elecsys TSH assay

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 Roche Diagnostics.

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
    We regret to inform you that in case the elecsys pth (1-84) assay lot 185522 (expiry date may 2016) and elecsys tsh assay lot 185522 (expiry date june-2017) were ever used on the same cobas 8000 modular analyzer series configuration (which includes cobas e 602 module), this will lead to the following consequences to the tsh: - a reduced number of tests per kit (100 instead of 200) - low recovery of pc universal level 2 (independent from the lot number) < -3sd - high recovery of precicontrol tsh and precicontrol thyro sensitive (ts) (independent from the lot number) > +3sd .

Device

Elecsys TSH assay

Manufacturer

Roche Diagnostics