Events

Field Safety Notices about Sysmex CS-2000i, CS-2100i, CS-2500 and CS-5100 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 Products GmbH.

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
    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
    Siemens healthcare diagnostics has confirmed that under very rare circumstances a false negative result may be reportable. the issue may only occur under the following conditions: • the initial result is falsely flagged with an antigen excess error that triggers an automatic remeasurement in a 1/19 dilution. and • the raw signal of the remeasurement is below the limit of blank (lob) of the method. under such conditions the low remeasurement raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low optical raw value. this raw value will be corrected by the dilution factor and can be deduced from calibration curve in a false low range. .

Device

Sysmex CS-2000i, CS-2100i, CS-2500 and CS-5100 System

Manufacturer

Siemens Healthcare Diagnostics Products GmbH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS