Events

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

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
    2019-02-10
  • 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
    Focus diagnostics has received customer complaints regarding mol2150 and mol2650 kits. two issues have been reported: 1) first with early cycle threshold (ct) in the sample wells of the direct amplification discs (mol1455, mol1452, mol1451) while performing the mol2150 and mol2650 testing (see figure 1 for some examples of early ct). this error may result in a false negative result, a false positive result or error code(s) 500 or 505. 2) additionally, some customers are reporting insufficient specimen volume errors which may result in higher invalid rates. in those cases, the error results in a report note statement of “insufficient specimen volume”. .

Device

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

Manufacturer

Focus Diagnostics