Events

Field Safety Notices about Cortisol Saliva Luminescence Immunoassay

According to Swiss Agency for Therapeutic Products, this field safety notices involved a device in Switzerland that was produced by IBL International GmbH.

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 ID
    Vk_20180115_09
  • Event Date Posted
    2018-01-17
  • Event Status
    2018-01-19
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20180115_09
  • Notes / Alerts
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Extra notes in the data
  • Reason
    Added new language.

Device

Cortisol Saliva Luminescence Immunoassay
  • Model / Serial
    RE62111, RE62119 | Catalog # RE62111/ Lots: LCL130 and LCL134, Catalog # RE62119 / Lots: LCL129, LCL131, LCL132 and LCL133
  • Product Description
    IVD: Free cortisol IVD, kit, chemiluminescent immunoassay
  • Manufacturer
    IBL International GmbH

Manufacturer

IBL International GmbH