Events

Field Safety Notices about MicroTrak Syphilis TPHA PK

According to Swiss Agency for Therapeutic Products, this field safety notices involved a device in Switzerland that was produced by Trinity Biotech plc.

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_20160921_09
  • Event Date Posted
    2016-10-10
  • Event Status
    2016-10-10
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20160921_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

MicroTrak Syphilis TPHA PK
  • Model / Serial
    8H60124 | D268003, Update: additional lots affected
  • Product Description
    IVD: Reagent, syphilis-reagin antibody
  • Manufacturer
    Trinity Biotech plc

Manufacturer

Trinity Biotech plc