Events

Field Safety Notices about CMV PCR Tests

According to Swiss Agency for Therapeutic Products, this field safety notices involved a device in Switzerland that was produced by Roche Molecular Systems, Inc. .

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_20071107_09
  • Event Date Posted
    2007-11-27
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20071107_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

Device

CMV PCR Tests
  • Model / Serial
  • Product Description
    IVD: Cytomegalovirus nucleic acid kit Chlamydia nucleic acid kit HBV nucleic acid kit Hepatitis C virus nucleic acid kit Human immunodeficiency virus 1 nucleic acid kit Human papillomavirus kit Neisseria kit
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.