Field Safety Notices about Stratus® CS Acute Care™ Diagnostics System Stratus® CS 200 Acute Care™ Diagnostics System

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 Siemens Healthcare Diagnostics Inc..

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
  • Event Country
  • 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
    Siemens healthcare has confirmed a software defect in the stratus cs acute care diagnostics system and stratus cs 200 acute care diagnostics system regarding testpak calibration and quality control (qc) status when a testpak is due to expire within 48 hours. depending on the calibration status, either an above assay range (aar) or an inaccurate value could potentially be reported when running a testpak that is due to expire within 48 hours. .

Device

  • Model / Serial
    Analyzer Serial Numbers Stratus® CS 200 Acute Care™ Diagnostics System 10714016 2.0.1 and 2.0.2 All serial numbers Stratus® CS Acute Care™ Diagnostics System 10444834 10453531 10453570 10453571 10470384 All software versions All serial numbers
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    AMPMDRS