Events

Field Safety Notices about ADVIA® 560 Hematology 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
    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 is conducting an urgent field safety notice for the advia 560 hematology system software. siemens has identified that software version 1.4.2133 does not trigger the following flags: · the w warning flag for detecting small sample volumes when using the international software configuration. if there is not enough sample volume of the patient’s blood when the sample is run, results may be lower than expected. this can occur if the required sample volume as defined in the advia 560 hematology system operator’s guide is not followed. · the g or l morphology flags for immature granulocytes (ig) and atypical lymphocytes (atyp), respectively. .

Device

ADVIA® 560 Hematology System

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS