Events

Field Safety Notices about Unicel® DxH™ 800 Coulter® Cellular Analysis 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 Beckman Coulter Diagnostics Limited.

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
    2015-12-11
  • 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
    Beckman coulter is initiating a field safety corrective action for the products listed above regarding the possibility of sample misidentification. this notice pertains to systems configured as a stand-alone dxh slidemaker stainer, dxh 800 or dxh 600, or as a workcell with multiple dxh 800s without a dxh slidemaker stainer. this letter contains important information that needs your immediate attention. .

Device

Unicel® DxH™ 800 Coulter® Cellular Analysis System

Manufacturer

Beckman Coulter Diagnostics Limited