Events

Field Safety Notices about UniCel DxH 800 Coulter Cellular Analysis System 629029, B24465, B24802, B68304, B66445, B63322 All UniCel DxH 600 Coulter Cellular Analysis System B23858 All

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 Beckman Coulter, 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
  • Date
    2017-04-24
  • 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
    There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. the events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result. in most cases, system flags and/or messages have accompanied the erroneous results, indicating the need to review the results. in rare instances, system flags and/or messages might be absent. .

Device

UniCel DxH 800 Coulter Cellular Analysis System 629029, B24465, B24802, B68304, B66445, B63322 Al...

Manufacturer

Beckman Coulter, Inc.