Events

Field Safety Notices about Simplexa™ Flu A/B & RSV Direct assay Simplexa™ HSV 1 & 2 Direct assay

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 Focus Diagnostics.

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
    2014-05-15
  • 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
    The purpose of this letter is to advise you that focus diagnostics is providing an urgent safety notice for a correction to the labeling for simplexa™ flu a/b & rsv direct (mol2650) and simplexa™ hsv 1&2 direct assays (mol2150). focus diagnostics received some customer complaints of simplexa flu a/b & rsv direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and direct amplification disc storage. to date, focus has not received any complaints for the simplexa hsv 1 & 2 direct assay used for commercial use. focus diagnostics is not requesting removal of any products from the test facility, but you should take extra precautions as described in the updated labeling. .

Device

Simplexa™ Flu A/B & RSV Direct assay Simplexa™ HSV 1 & 2 Direct assay

Manufacturer

Focus Diagnostics