Events

Field Safety Notices about Buffer Reagent Premier A, Buffer Reagent Premier B

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
    2017-02-24
  • 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 would like to inform you that we have received reports of problems in testing control samples (quality control checks) with the above-mentioned reagent series after the system is started or ready for standby. after examination we confirmed that in the results of the first two (2) tests carried out with these series of reagents after starting the system or turning it off from standby mode, there may be slight bias when testing the control sample as a sample of the patient.

Device

Buffer Reagent Premier A, Buffer Reagent Premier B
  • Model / Serial
    6873, 6669, 6374, 6859, 6639, 6506, 6528, 6633, 6526
  • Manufacturer
    Trinity Biotech

Manufacturer

Trinity Biotech