Events

Field Safety Notices about Captia Syphilis IgG Kit

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 Trinity Biotech.

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
  • Date
    2016-11-03
  • 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
    Trinity biotech was informed of a customer's concern about the possible under-abundance of red in positive high titre control. the color is not the same with all kits as some vials may be red and some may be colorless. the investigation showed that the color red was fading. in addition, trinity performed performance tests on both red and colorless high titre positive control vials and found that the kit continued to meet all quality assurance criteria for batch release. the absence of color does not affect the performance of a kit that meets all the criteria for performing a valid test. the color red is inert and is usually added for visual distinction.

Device

Captia Syphilis IgG Kit

Manufacturer

Trinity Biotech