Events

Field Safety Notices about Stat Profile Prime Analyzers

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 Nova Biomedical Corporation.

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
    2017-06-09
  • 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
    Nova biomedical corporation has recently become aware of a software issue on the stat profile prime analyzers listed above when using stat profile prime auto-cartridge quality control (a-qc) materials (also referred to as “onboard quality control” or “internal quality control”). stat profile prime analyzers that do not utilize auto-cartridge quality control materials are unaffected by this software issue. stat profile prime analyzers that only use traditional external quality control materials (glass ampules) are unaffected by this software issue. .

Device

Stat Profile Prime Analyzers
  • Model / Serial
    PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG System with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation